Medical devices

ABSTRACT

In at least one embodiment, a medical device can comprise an elongate outer sheath that extends along a sheath longitudinal axis and defines a central lumen extending therethrough, the elongate outer sheath can comprise a proximal sheath portion and a distal sheath portion. A first guidewire can comprise a first guidewire end and a second guidewire end, the first guidewire can extend from the first and second guidewire ends through the central lumen and can form a distal looped portion. An occlusion device can be disposed at a distal end of an elongate flexible shaft. The elongate flexible shaft can extend from the proximal sheath portion through the central lumen. The occlusion device can include a guide lumen through which the first guide wire passes.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. provisional patent applicationNo. 62/119,800, filed 23 Feb. 2015, which is hereby incorporated byreference as though fully set forth herein.

BACKGROUND

a. Field

The instant disclosure relates to medical devices.

b. Background Art

Various conditions can affect the heart, which can alter a ‘normal’functioning of the heart. Such conditions can include atrialarrhythmias, which include conditions in which an electrical activity ofthe heart is irregular, faster, or slower than normal. Treatment ofatrial arrhythmias can often involve accessing the heart epicardially orendocardially with devices that can aid in detecting and/or treating thearrhythmias.

SUMMARY

In at least one embodiment, a medical device can comprise an elongateouter sheath that extends along a sheath longitudinal axis and defines acentral lumen extending therethrough, the elongate outer sheath cancomprise a proximal sheath portion and a distal sheath portion. A firstguidewire can comprise a first guidewire end and a second guidewire end,the first guidewire can extend from the first and second guidewire endsthrough the central lumen and can form a distal looped portion. Anocclusion device can be disposed at a distal end of an elongate flexibleshaft. The elongate flexible shaft can extend from the proximal sheathportion through the central lumen. The occlusion device can include aguide lumen through which the first guide wire passes. The firstguidewire can be configured to be moved distally with respect to theouter sheath. The distal looped portion can be disposed distally withrespect to the distal sheath portion. The occlusion device can beconfigured to be moved along the first guidewire.

In at least one embodiment, a medical device can comprise an elongateouter sheath that extends along a sheath longitudinal axis and defines acentral lumen extending therethrough, the elongate outer sheath cancomprise a proximal sheath portion and a distal sheath portion. A firstguidewire can comprise a first guidewire end and a second guidewire endand a second guidewire can comprise a third guidewire end and a fourthguidewire end. The first and second guidewires can extend from theirrespective guidewire ends through the central lumen and can form a firstguidewire distal looped portion and a second guidewire distal loopedportion, respectively. An occlusion device can be disposed at a distalend of an elongate flexible shaft, the elongate flexible shaft canextend from the proximal sheath portion through the central lumen. Theocclusion device can include a first guide lumen through which the firstguidewire passes and a second guide lumen through which the secondguidewire passes. The occlusion device can include a first jaw to whichthe first guide lumen is connected and a second jaw to which the secondguide lumen is connected. The first jaw and the second jaw can beconnected via a pivot point.

In at least one embodiment, a method of using a medical device cancomprise deploying a first guidewire distal looped portion and a secondguidewire distal looped portion of the medical device from a distal endof an elongate outer sheath that extends along a sheath longitudinalaxis and defines a central lumen extending therethrough. The method caninclude guiding an occlusion device disposed at a distal end of anelongate flexible shaft along the first guidewire distal looped portionand the second guidewire distal looped portion. The method can includeactivating the occlusion device via a control disposed proximally of thedistal end of the elongate outer sheath.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts an expansion catheter system that can be used in relationto cardiac access, visualization, sensing, and/or ablation, inaccordance with embodiments of the present disclosure.

FIG. 2A depicts components comprising part of the exemplary expansioncatheter system depicted in FIG. 1, in accordance with embodiments ofthe present disclosure.

FIG. 2B is a fragmentary, isometric view of a steerable expanding shroudextending from an inner sheath that is slidingly mounted in an outersheath, and shows the steerable expanding shroud in a first deployedstate and an ablation device extending from the distal end of anexpansion catheter associated with the exemplary expansion cathetersystem in FIG. 1, in accordance with embodiments of the presentdisclosure.

FIG. 2C depicts the steerable expanding shroud in a second deployedstate and an ablation device extending from a distal end of theexpansion catheter associated with the exemplary expansion cathetersystem in FIG. 1, in accordance with embodiments of the presentdisclosure.

FIG. 3 depicts the steerable expanding shroud in a third deployed state,an ablation device, and a visualization device extending from the distalend of the expansion catheter associated with the exemplary expansioncatheter system in FIG. 1, in accordance with embodiments of the presentdisclosure.

FIG. 4 depicts the steerable expanding shroud in a fourth deployed stateand a visualization device extending into a volume defined within thesteerable expanding shroud adjacent the distal end of the expansioncatheter associated with the exemplary expansion catheter system in FIG.1, in accordance with embodiments of the present disclosure.

FIG. 5A depicts an embodiment of an expansion catheter system thatincludes a steerable expanding shroud, an occlusion device in a firstdeployed state, and a visualization device extending from a distal endof the outer sheath comprising part of the expansion catheter, inaccordance with embodiments of the present disclosure.

FIG. 5B depicts the steerable expanding shroud, the occlusion device ina second deployed state, and the visualization device extending from thedistal end of the outer sheath comprising part of the expansioncatheter, in accordance with embodiments of the present disclosure.

FIG. 5C is a view from the visualization device in FIG. 5B, inaccordance with embodiments of the present disclosure.

FIG. 6A depicts the steerable expanding shroud, an ablation device, anda visualization device extending from a distal end of the steerableexpanding shroud associated with the exemplary expansion catheter systemin FIG. 1, in accordance with embodiments of the present disclosure.

FIG. 6B is a view from the visualization device in FIG. 6A, inaccordance with embodiments of the present disclosure.

FIG. 6C depicts an elongated suction ablation device, in accordance withembodiments of the present disclosure.

FIG. 6D is a stylized representation of a view from the visualizationdevice in FIG. 6A, in accordance with embodiments of the presentdisclosure.

FIG. 7 is an isometric side and front view of a visualization, pacing,sensing, and/or ablation device, in accordance with embodiments of thepresent disclosure.

FIG. 8A is a side view of the visualization, pacing, sensing, and/orablation device similar to that depicted in FIG. 7 attached to a distalend of a catheter, in accordance with embodiments of the presentdisclosure.

FIG. 8B depicts a cross section of the catheter shown in FIG. 8A, inaccordance with embodiments of the present disclosure.

FIG. 9 depicts a stylized representation of a view from a visualizationdevice within the visualization, pacing, sensing, and/or ablation devicein FIG. 7, in accordance with embodiments of the present disclosure.

FIG. 10A is an isometric side and bottom view of a visualization,pacing, sensing, and/or ablation device, in accordance with embodimentsof the present disclosure.

FIG. 10B is a bottom view of a visualization, pacing, sensing, and/orablation device depicted in FIG. 10A, in accordance with embodiments ofthe present disclosure.

FIG. 11A is a side view of a visualization, pacing, sensing, and/orablation device, in accordance with embodiments of the presentdisclosure.

FIG. 11B is a front view of the visualization, pacing, sensing, and/orablation device depicted in FIG. 11A, in accordance with embodiments ofthe present disclosure.

FIG. 12A is a front view of an alternate embodiment of thevisualization, pacing, sensing, and/or ablation device in FIG. 11B witha hinge and in a folded state, in accordance with embodiments of thepresent disclosure.

FIG. 12B is a front view of the visualization, pacing, sensing, and/orablation device in FIG. 12A in an opened and partially expanded state,in accordance with embodiments of the present disclosure.

FIG. 12C is a front view of the visualization, pacing, sensing, and/orablation device in FIG. 12A in an opened and expanded state, inaccordance with embodiments of the present disclosure.

FIG. 13A is an isometric front and side view of a portal access devicein a retracted state, in accordance with embodiments of the presentdisclosure.

FIG. 13B is a front view of the portal access device in FIG. 13A in theretracted state, in accordance with embodiments of the presentdisclosure.

FIG. 13C is a cross-sectional side view of the portal access device inFIG. 13B along line A-A in a retracted state, in accordance withembodiments of the present disclosure.

FIG. 13D is a cross-sectional side view of the portal access device inFIG. 13C in a penetrating state, in accordance with embodiments of thepresent disclosure.

FIG. 13E is a cross-sectional side view of the portal access device inFIG. 13C in an engaged state, in accordance with embodiments of thepresent disclosure.

FIG. 13F is an isometric front and side view of the portal access devicein FIG. 13A in an engaged state, in accordance with embodiments of thepresent disclosure.

FIGS. 14A to 14C depict various embodiments of a portal access device,in accordance with embodiments of the present disclosure.

FIG. 14D is an isometric side and front view of the distal end of theportal access device in FIG. 14B, in accordance with embodiments of thepresent disclosure.

FIG. 14E is a side view of the distal end of the portal access device inFIG. 14B, in accordance with embodiments of the present disclosure.

FIG. 14F is an isometric side view of a proximal end of the portalaccess device in FIG. 13A, in accordance with embodiments of the presentdisclosure.

FIG. 15A is an isometric side and front view of an access propagationdevice in accordance with embodiments of the present disclosure.

FIG. 15B is a side view of the access propagation device in FIG. 15Abeing inserted into access tape, in accordance with embodiments of thepresent disclosure.

FIG. 16 is an isometric bottom view of an access retrieval device thatincludes an endoscope hood, in accordance with embodiments of thepresent disclosure.

FIG. 17A is an isometric bottom view of an embodiment of an accessretrieval device that includes an endoscope hood, in accordance withembodiments of the present disclosure.

FIG. 17B is an isometric bottom view the access retrieval device thatincludes the endoscope hood in FIG. 17A, in accordance with embodimentsof the present disclosure.

FIGS. 18A to 18C is an isometric bottom view of additional embodimentsof an access retrieval device, in accordance with embodiments of thepresent disclosure.

FIG. 18D is an isometric side view of a distal end of the accessretrieval device in FIG. 18B, in accordance with embodiments of thepresent disclosure.

FIGS. 18E to 18G is an isometric bottom view of the additionalembodiments of the access retrieval devices depicted in FIGS. 18A to18C, in accordance with embodiments of the present disclosure.

FIG. 19A is a side view of an endoscope hood device, in accordance withembodiments of the present disclosure.

FIG. 19B is an isometric side view of the endoscope hood device in FIG.19A, in accordance with embodiments of the present disclosure.

FIG. 19C is a cross-sectional side view of the endoscope hood device inFIG. 19A, in accordance with embodiments of the present disclosure.

FIG. 19D is an isometric front and side view of the endoscope hooddevice in FIG. 19A, in accordance with embodiments of the presentdisclosure.

FIG. 19E is an isometric bottom, front, and side view of the endoscopehood device in FIG. 19A, in accordance with embodiments of the presentdisclosure.

FIG. 19F is an isometric bottom and side component view of the endoscopehood device in FIG. 19A, in accordance with embodiments of the presentdisclosure.

DETAILED DESCRIPTION

FIG. 1 depicts an expansion catheter system 100 that can be used inrelation to cardiac access, visualization, and/or ablation, inaccordance with embodiments of the present disclosure. In someembodiments of the present disclosure the expansion catheter system 100can include an expansion catheter 102, a tool (e.g., catheter handle 104connected to a steerable catheter 106), and endoscope 108. The expansioncatheter 102 can have a distal end and a proximal end. The catheterhandle 104 can have various componentry included in the catheter handle104 for control (e.g., deflection of the distal end of the expansioncatheter 102). A proximal end of a steerable catheter 106 can beconnected with a distal end of the catheter handle 104 and deflection ofa distal portion of the steerable catheter 106 can be controlled via thecatheter handle 104. For example, approximately the last three inches ofthe steerable catheter 106 can be controlled via the various componentryincluded in the catheter handle 104. An inner sheath 110 can beconcentric with the steerable catheter 106 and can extend distally overthe steerable catheter 106.

In some embodiments, a space can exist between the proximal end of theinner sheath 110 and the distal end of the catheter handle 104, leavinga portion of the steerable catheter 106 exposed. In some embodiments, anouter sheath 112 can be concentric with the inner sheath 110 and canextend distally from and can be connected to a stability handle 114towards the distal end of the expansion catheter 102. An outer diameterof the inner sheath 110 can be very close to an inner diameter of theouter sheath 112, such that the inner sheath 110 can slide within theouter sheath 112.

In some embodiments, the outer sheath 112 can be an elongate outersheath 112 that extends along a sheath longitudinal axis and defines acentral lumen extending therethrough. The elongate outer sheath 112 cancomprise a proximal sheath portion and a distal sheath portion.

As discussed further herein, various devices and associated componentscan be inserted through the steerable catheter 106 and can be slidaxially through the steerable catheter 106, such that the devices canexit through the distal end of the expansion catheter 102. As shown inFIG. 1, an endoscope cable 116 can extend through a proximal end of thecatheter handle 104, through the catheter handle 104, through thesteerable catheter 106 to the endoscope 108 located in the distal end ofthe expansion catheter 102. In some embodiments, control circuitry 118associated with the endoscope 108 can be located proximally with respectto the catheter handle 104. In an example, the endoscope 108 can be aCMOS endoscope.

In some embodiments, the inner sheath 110 can be slid distally withrespect to the outer sheath 112, such that a steerable expanding shroud160 is pushed out of the distal end of the outer sheath 112, as furtherdescribed herein. A physician can grasp the stability handle 114 tocause the outer sheath 112 to remain stationary with respect to thecatheter handle 104. Alternatively, or in addition, the stability handle114 can be moved proximally with respect to the inner sheath 110 tocause the steerable expanding shroud 160 to be deployed from the distalend of the expansion catheter 102.

Because the distal end of the expansion catheter 102 can be positionedin close relation to a tissue surface, there can be some relative motionoccurring between the outer and inner sheath to deploy the steerableexpanding shroud 160. In an example, the outer sheath 112 can be pulledback just slightly via the stability handle 114 in concert with pushingthe inner sheath 110 distally, which deploys the expansion catheter 100portion. As the steerable expanding shroud 160 expands, it can naturallypull back. Thus, to keep the distal end of the steerable expandingshroud 160 and the scope in the same spot, the inner sheath 110 can beadvanced farther than the outer sheath 112 is retracted. As thesteerable expanding shroud 160 is retracted to full diameter by the pullsutures, the whole system may need to be advanced. In some embodiments,the outer sheath 112 can be held still in relation to a patient. In someembodiments, a stationary holding assist device can be utilized to holdthe outer sheath 112 in position in relation to a target tissue.

FIG. 2A depicts components associated with the exemplary expansioncatheter system 100 in FIG. 1, in accordance with embodiments of thepresent disclosure. In some embodiments, as described in relation toFIG. 1, various devices and associated components can be insertedthrough an inner sheath 130. The inner sheath 130 can have a length,defined by line b-b of approximately 25 centimeters, although the innersheath 130 can be shorter or longer than 25 centimeters. In an example,and as depicted, the inner sheath 130 can be made from a semi-rigid,clear tube. As used herein, a tube can be a hollow cylinder, althoughthe tube can be formed in various other shapes, such as a square,triangle, etc.

The inner sheath 130 can be flexible, such that it can move with thesteerable catheter 106 (e.g., can be deflected), depicted in FIG. 1. Theinner sheath 130 can be disposed within a central lumen formed by theelongate outer sheath 136 and can be coaxial with the outer sheath 136.In some embodiments, a distal end of the inner sheath 130 can extendproximally to the distal end of the expansion catheter. Located betweenthe distal end of the inner sheath 132 and the distal end of theexpansion catheter 129, can be a steerable expanding shroud 160 and/orother devices. For example, the steerable expanding shroud 160 can belocated (e.g., stored) in a distal portion 134 of the expansion catheter129 defined by line a-a. In some embodiments, line a-a can have a lengthof approximately 9.5 cm, although the distal portion 134 of theexpansion catheter 129 that houses the steerable expanding shroud and/orother devices can have a length that is longer or shorter than 9.5 cm.

In some embodiments, an ablation device and/or an occlusion device(e.g., occlusion clip device) can also be inserted inside of thesteerable expanding shroud 160, as further described herein. Thesteerable expanding shroud 160 can be connected to the distal end of theinner sheath 132. In some embodiments, the inner sheath 130 can beconfigured to axially move with respect to the outer sheath 136. As theinner sheath 130 is moved distally with respect to the outer sheath 136,which can also be made of similar material as the inner sheath 130, thesteerable expanding shroud 160 can be forced from the distal end of theouter sheath 138 and can expand, as discussed further herein.

In some embodiments, a length of the outer sheath, defined by line c-ccan be approximately 21 centimeters, although the length of the outersheath can be less than or greater than 21 centimeters. In someembodiments, a length from the distal end of the outer sheath 136 to theproximal end of the inner sheath 130, defined by line d-d, can beapproximately 33 centimeters, although the length can be greater than orless than 33 centimeters.

In some embodiments, various other components associated with devicesinserted through a central lumen of the inner sheath 130 can also beinserted through the inner sheath 130. For example, sutures 140-1, 140-2that are connected to a distal end of the steerable expanding shroud 160can pass through the central lumen of the inner sheath 130 and can beconnected to a ring 142 (e.g., control, control ring) or other devicewhich can cause each of the sutures to be tensioned independently fromone another. Although two sutures 140-1, 140-2 are depicted, a thirdsuture, a third suture may be used. Hereinafter, sutures 140-1, 140-2are generally referred herein as sutures 140.

In some embodiments, one or more sutures (e.g., three sutures, foursutures, eight sutures, nine sutures) can be connected to the distal endof the steerable expanding shroud. In some examples, a connection pointbetween each of the sutures 140 and the steerable expanding shroud 160can be equidistant from one another around a distal circumference of thesteerable expanding shroud 160. In some embodiments, one or more o-rings144 (e.g., frictional engagement devices) can be placed over the innersheath 130 and positioned distally to a proximal end of the inner sheath130. One or more suture holes can be formed distally from the o-rings144, through which the sutures 140 can pass. The sutures 140 can extendfrom the distal end of the steerable expanding shroud through thecentral lumen of the inner sheath 130, out of the suture holes andbetween an outer surface of the inner sheath 130 and an inner surface ofthe o-rings 144, such that the o-rings 144 provide tension on thesutures. Thus, a tension applied to the sutures via the ring 142 can bemaintained via frictional forces enacted by the o-rings 144 on thesutures.

Additionally, in some embodiments, the occlusion device advancing andopening controls 146 can extend through the central lumen of the innersheath 130 to an occlusion device inside of the distal end of the outersheath 136. The occlusion device (or other mechanism) can be deployedfrom the distal end of the expansion catheter 129 by advancing the pushhousing (e.g., cable 150 housing) toward the distal end of the expansioncatheter 129. In some embodiments, the occlusion device can includejaws, as depicted in FIGS. 5A to 5C. Control of the occlusion devicejaws can be provided by regressing a pull knob 148 on the cable 149proximally. For example, the cable 149 can be connected to the occlusiondevice 204 and can be pulled and/or pushed to open and/or close the jawsassociated with the occlusion device 204. In some embodiments, the cablehousing can counter the force applied to the cable 149 and can provide alumen through which the cable 149 can pass.

In some embodiments, guidewire rails 152-1, 152-2, further depicted inrelation to FIGS. 5A to 5C for example, can extend through the centrallumen of the inner sheath 130 to a distal end of the expansion catheter129 to provide for control and/or positioning of various devicesincluded in or near the distal end of the expansion catheter 129. Insome embodiments, a proximal end of the steerable expanding shroud 160can extend further proximally down the outer sheath, resulting in alonger steerable expanding shroud, which can form a tunnel that islonger and/or larger in diameter. In some embodiments, a longersteerable expanding shroud can form a tunnel that extends from apatient's heart to a position that is outside of the patient's body. Insome embodiments, a longer steerable expanding shroud can be moreflexible than a shorter steerable expanding shroud, which canaccommodate to an anatomy better than a straight or fixed curved shaft.

In some embodiments, cuts can be made across a portion (e.g., distalend) of the inner sheath 130 and/or outer sheath 136. In someembodiments, the cuts can be perpendicular to a longitudinal axis of theinner sheath 130 and/or outer sheath 136. In some embodiments, cuts canbe made on each side of the inner sheath 130 and/or outer sheath 136,such that the cuts are diametrically opposed to one another, whichleaves two spines that are diametrically opposed to one another that runalong the inner sheath 130 and/or outer sheath 136 axially. In someembodiments, 20 to 35 cuts can be made in the most distal three inchesof the inner sheath 130 and/or outer sheath 136, although more cuts orfewer cuts can be made. The cuts can allow either the inner sheath 130and/or outer sheath 136 to flex more easily and/or flex in a singleplane.

In some embodiments, the inner sheath 130 and/or outer sheath 136 can bepassively flexible and steered with a deflectable shaft (e.g., steerablecatheter 106) passing through the inner sheath 130. Alternatively, pullmembers (e.g., wires) can be attached to a distal end of the innersheath 130, which can cause the distal end of the expansion catheter 129to deflect when tension is applied to one or more of the pull members.In some embodiments, a ribbon can be attached to the distal end of theinner sheath 130, which can cause the distal end of the expansioncatheter 129 to deflect when tension is applied to one or more of thepull members. In an example, ribbons can be used to increase tensilestrength without adding significantly to diameter requirements.

In some embodiments, when the axially perpendicular cuts are made inboth the inner and/or outer sheath 130, 136, the cuts can interfere witheach other and cause friction between the sheaths 130, 136, when thesheaths 130, 136 are deflected and/or rotated about the longitudinalaxis. As such, one of the inner and/or outer sheath 130, 136 can havelongitudinal cuts that extend along a longitudinal axis and areperpendicular to the axially perpendicular cuts. In some embodiments,one of the inner sheath 130 and/or outer sheath 136 can have alternatingaxial and axially perpendicular cuts. For example, a first set of cutscan be diametrically opposed to each other and can be axiallyperpendicular, a next adjacent set of cuts can be diametrically opposedto one another and can extend axially, followed by another set of cutsthat are diametrically opposed to each other and are axiallyperpendicular. This pattern can continue along a particular length of atleast one of the inner and outer sheath.

In some embodiments, the inner sheath 130 and/or outer sheath 136 canhave diametrically opposed sets of cuts that are perpendicular to alongitudinal axis of the inner sheath 130 and/or outer sheath 136, witheach adjacent set of cuts being disposed at 90 degrees with respect toone another. As such, interference between the inner sheath 130 andouter sheath 136 can be avoided because the rotationally alternatingdiametrically opposed perpendicular sets of cuts allow for the innersheath 130 and/or outer sheath 136 to deflect in any direction (e.g.,plane), thus avoiding interference when the inner sheath 130 and/orouter sheath 136 are configured to deflect within one deflection plane,and a deflection plane of the inner sheath 130 is perpendicular to adeflection plane of the outer sheath 136. In some embodiments, the innerand outer sheath may be comprised of flexible material without cuts andcan

FIG. 2B is a fragmentary, isometric view of a steerable expanding shroud160 extending from an inner sheath 130 that is slidingly mounted in anouter sheath 136, and shows the steerable expanding shroud 160 in afirst deployed state and an ablation device 162 extending from thedistal end of an expansion catheter 129 associated with the exemplaryexpansion catheter system 100 depicted in FIG. 1, in accordance withembodiments of the present disclosure. In some embodiments, the ablationdevice 162 can be an occlusion device. As depicted in FIG. 2B, thesteerable expanding shroud 160 has been pushed from the distal end ofthe outer sheath 136 by the inner sheath 130, to which the steerableexpanding shroud is connected. As the steerable expanding shroud 160exits the distal end of the outer sheath 136, the steerable expandingshroud 160 can expand.

In some embodiments, the steerable expanding shroud 160 can be made fromwoven nitinol wire, which can maintain a preformed shape. However, thesteerable expanding shroud 160 can be formed from other materials. Insome embodiments, when the steerable expanding shroud 160 is placedwithin (e.g., retracted into) the distal end of the expansion catheter129, the steerable expanding shroud 160 can lengthen as the wovennitinol wire is compressed. As such, when the steerable expanding shroud160 is deployed from the distal end of the expansion catheter 129, anoverall length of the steerable expanding shroud 160 can shortensomewhat. As depicted in FIG. 2B, no tension is applied to the sutures140-1, 140-2, resulting in the steerable expanding shroud 160 having nodeflection with respect to a longitudinal axis running along theexpansion catheter 129.

In some embodiments, the device 162 extending from the distal end of theexpansion catheter 129 can be an ablation device, visualization device,and/or other type of device. The device 162 can have a tether 164, whichcan be connected to a proximal end of the device 162 and can extendproximally through the expansion catheter 129. In an example, the tether164 can be a cable that includes a power and/or control wire. In someembodiments, the tether 164 can be semi-rigid, such that a force can beapplied to a proximal end of the tether 164, which can be transferredthrough the tether 164 to the device 162, thus moving the device 162proximally and/or distally. In some embodiments, and as depicted in FIG.2B, the device 162 can be connected to a distal end of a steerablecatheter 129. In some embodiments, the steerable catheter 126 can beapproximately 12 French and can be deflectable along a distal portion(e.g., 4 to 5 centimeters).

In some embodiments, the expansion catheter system 100 can be used tointroduce a device 162 into the interstitial space between thepericardial sac of the heart and the myocardium of the heart. The distalend of expansion catheter 129 can be introduced through the pericardialsac at or near an apex of the heart (e.g., subxiphoid) and the steerableexpanding shroud 160 can be deployed. Upon deployment of the steerableexpanding shroud 160, a tunnel can be created between thecircumferential walls of the steerable expanding shroud 160, creatingspace for a device to operate in. For example, where the device 162 isan endoscope, the lens can be kept clear of tissues/fluid and the fieldof view can be enlarged by the steerable expanding shroud 160. Likewise,where the device is an ablation device, tissues that are not involvedwith a therapy applied by the ablation device can be kept clear alongwith fluid. In some embodiments, an irrigation tube can also extend downa central lumen of the expansion catheter 129 and/or a lumen created bythe steerable expanding shroud 160 and can apply irrigation fluid to thesite where the ablation device is operating.

FIG. 2C depicts the steerable expanding shroud 160 in a second deployedstate and the device 162 extending from a distal end of the expansioncatheter 129 associated with the exemplary expansion catheter system 100in FIG. 1, in accordance with embodiments of the present disclosure. Asdepicted, the device 162 has remained in approximately the same place asshown in FIG. 2B, while the steerable expanding shroud 160 has beenretracted proximally through a tension that has been approximatelyequally applied to the sutures 140 (e.g., via ring 142). As can be seen,the suture 140 running through a central lumen of the expansion catheter129, which can be defined by the inner sheath 130, is now taught due tothe tension applied to the suture via, for example, the ring 142,depicted in FIG. 2A. In addition, the outer sheath 136 and inner sheath130 have remained in approximately the same position with respect to oneanother.

In some embodiments, retracting the steerable expanding shroud 160 cancause a diameter created by the steerable expanding shroud 160 toincrease, as seen in FIG. 2C, which can create more room for devices tooperate. In addition, as the steerable expanding shroud 160 isretracted, as depicted in FIG. 2C, the woven fibers of the steerableexpanding shroud 160 can become more circumferential, which can causethe woven walls of the steerable expanding shroud 160 to become morerigid. For example, the woven walls of the steerable expanding shroud160 can become more resistant to deflecting inward towards a lumenformed by the steerable expanding shroud 160 when a force is applied toan outer portion of the woven walls of the steerable expanding shroud160.

In some embodiments, the steerable expanding shroud 160 can include arigid and/or semi-rigid ring that extends around a distal most portionof the steerable expanding shroud 160. For example, the ring can beinterwoven between fibers of the woven steerable expanding shroud 160.As such, tension applied to the sutures 140 can be directly translatedto the interwoven ring, resulting in a more consistent application offorce around a distal circumference of the steerable expanding shroud160. In some embodiments, the sutures can be attached directly to thefibers of the woven steerable expanding shroud 160.

FIG. 3 depicts the steerable expanding shroud 160 in a third deployedstate, a device 162, and an endoscope 176 extending from the distal endof the expansion catheter 129 associated with the exemplary expansioncatheter system 100 in FIG. 1, in accordance with embodiments of thepresent disclosure. In some embodiments, an endoscope 176 can initiallybe placed in the expansion catheter 129 for guidance to a particularlocation and can then be removed, such that a different device can bedeployed from the distal end of the expansion catheter 129. In anexample, once the different device is inserted in the expansion catheter129 or deployed from the distal end of the expansion catheter 129, theendoscope 176 can be reinserted.

In some embodiments, the expansion catheter 129 can be made moreflexible when guiding the catheter into place by just having theendoscope 176 in place. As depicted in FIG. 3, the expanding cathetercan been deflected laterally with respect to the longitudinal axisrunning along the expansion catheter 129. In an example, if threesutures are attached to the distal end of the steerable expanding shroud160, a greater tension can be applied to one of the sutures resulting ina lateral deflection of the steerable expanding shroud 160 in adirection from the longitudinal axis towards that suture. In an example,the lateral deflection of the steerable expanding shroud 160 can bebeneficial because the lateral deflection of the expanding shroud 160can allow the distal circumference of the steerable expanding shroud 160to make more complete contact with tissue. For instance, when alongitudinal axis defined by the expansion catheter 129 is notperpendicular with the myocardium, the distal circumference of thesteerable expanding shroud 160 can be deflected such that minimal gapsor no gaps exist between the distal circumference of the steerableexpanding shroud and the myocardium.

As seen in FIG. 3, the device 162 can be extended from the distal end ofthe outer sheath 136, such that it resides outside of the steerableexpanding shroud 160. In some embodiments, an additional device (e.g.,endoscope) can extend down the central lumen of the expansion catheter129 and out of the distal end of the outer sheath 136. As such, a viewcan be provided via the endoscope 176. In some embodiments, thesteerable expanding sheath 160 can be deflected to provide the device162 with a maximum working range and the endoscope 176 a maximum fieldof view.

FIG. 4 depicts a steerable expanding sheath 186 in a fourth deployedstate and a visualization device 188 (e.g., endoscope) extending into avolume defined within the steerable expanding shroud adjacent the distalend of an expansion catheter 190 associated with the exemplary expansioncatheter system 100 in FIG. 1, in accordance with embodiments of thepresent disclosure. As previously discussed, via selective tensioning ofthe sutures attached to the distal circumference of the steerableexpanding shroud the steerable expanding shroud can be retracted,protracted and/or expanded by different amounts and/or laterallydeflected by different amounts and/in different directions.

Some embodiments of the present disclosure include an endoscope thatincludes an inflatable bladder 192 at the distal tip. The inflatablebladder 192 is shown as inflated and/or partially inflated in FIG. 4. Inan example, the inflatable bladder 194 can include an inner wall that iscoaxial with an outer surface of the endoscope 188 and an outer wallthat is coaxial with the inner wall of the inflatable bladder 194. Theproximal end and the distal end of the inner and outer walls of theinflatable bladder 194 can be connected to one another, such that a sealis formed. An inflation port can exist in the inner wall, outer wall,and/or at the proximal connection point between the inner wall and theouter wall of the inflatable bladder 194. As such, air or liquid can beintroduced into the inflatable bladder 194 through the inflation portvia an inflation tube extending proximally down the expansion catheter.As air or liquid is pumped into the inflatable bladder 194, an annularshape and/or other shape can be formed.

In some embodiments, the inflatable bladder 194 can extend just distallyof the endoscope 188, such that any abrupt edges associated with theendoscope 188 can be covered by the inflatable bladder 192, thuspreventing tissue injury from occurring due to accidental and/orintentional contact between the endoscope 188 and the tissue of thepatient. In some embodiments, an edge of the steerable expanding shroud186, inner sheath, or outer sheath 194 can be covered or tangentiallyshielded by an inflatable bladder. For example, an inflatable bladdercan be positioned around a distal edge (e.g., distal outercircumference) of the steerable expanding shroud 186; around a distalexterior circumference of the outer sheath 194; and/or around a distalexterior circumference of the inner sheath to prevent tissue injury fromoccurring due to accidental and/or intentional contact between thesteerable expanding shroud 186; distal exterior circumference of theouter sheath 194; and/or distal exterior circumference of the innersheath and the tissue of the patient.

In some embodiments, the inflatable bladder 192 may be used to assist inpositioning the scope within the shroud 186. Deflection of the distaltip of the scope can swing the camera view along the arc of radius ofthe deflection. The bladder 192 may stabilize the scope tip with regardto the shroud 186, keeping the deflection sweep of the camera tipminimized but yet allowing its angle to change for desired view angle.

In some embodiments, the inflatable bladder 192 can be a single layer ofa flexible and/or elastic material. For example, the inflatable bladder192 can be a hollow cylinder formed of a flexible and/or elasticmaterial that is connected to the outer wall of the endoscope at adistal end and proximal end of the hollow cylinder. The connectionbetween the distal end and the proximal end of the inflatable bladder192 and the outer wall of the endoscope 188 can be fluid tight, suchthat the space existing between an inner wall of the inflatable bladder192 and the outer wall of the endoscope 188 can be inflated.

FIG. 5A depicts an embodiment of an expansion catheter system 200 thatincludes a steerable expanding shroud 202, an occlusion device 204 in afirst deployed state, and a visualization device 206 extending from adistal end of the outer sheath 208 comprising part of the expansioncatheter 210, in accordance with embodiments of the present disclosure.As discussed herein, the expansion catheter 210 can include the outersheath 208 and the steerable expanding shroud 202 that is deployed fromthe distal end of the outer sheath 208.

In some embodiments, the steerable expanding shroud 202 can be deployedin an opening in the pericardium, such that an outer circumference ofthe steerable expanding shroud 202 ‘grabs’ the pericardium, thusstabilizing the expansion catheter 210 and preventing movement of theexpansion catheter 210 with respect to the pericardium. In someexamples, the expansion catheter 210 may be able to lift the pericardiumfrom the heart to create an enlarged interstitial space between thepericardium and the heart. This can allow for increased room fordeployment of devices from the expansion catheter 210 in theinterstitial space between the pericardium and the heart. As such,devices may be deployed wholly within the steerable expanding shroud 202(e.g., within a lumen formed by the steerable expanding shroud 202),partially within the steerable expanding shroud 202, and/or outside ofthe steerable expanding shroud 202.

In some embodiments, an occlusion device 204 can be deployed from thedistal end of the outer sheath 208, as discussed herein. In someembodiments, the occlusion device 204 can be used for occlusion of theleft atrial appendage. In some embodiments, the occlusion device 204 caninclude a guide lumen through which a first guide wire passes (e.g., topguide wire 228 or bottom guide wire 230). The occlusion device 204 caninclude a bottom occlusion clip 212 and a top occlusion clip 214. Thebottom occlusion clip 214 and the top occlusion clip 214 can beconnected to a bottom support jaw 216 and a top support jaw 218,respectively, which can be configured to be closed upon one another. Inan example, electrodes can be disposed along a top occlusion surface 220of the top occlusion clip 214 and a bottom occlusion surface 222 of thebottom occlusion clip 212. In some embodiments, the top occlusionsurface 220 and the bottom occlusion surface 222 can face one another.The electrodes can be disposed along the entire top and bottom occlusionsurfaces 220, 222 and/or along a partial length of the top and bottomocclusion surfaces 220, 222. However, in some embodiments, the topocclusion clip 214 and the bottom occlusion clip 212 may containablation electrodes.

In some embodiments, the occlusion device can be connected to a distalend of a clip catheter (e.g., elongate flexible shaft 224) via a clipmount. The elongate flexible shaft 224 can extend from the proximalsheath portion through the central lumen of the outer sheath and/or Insome embodiments, the bottom support jaw and the top support jaw can beconnected at a clip hinge 226 (e.g., pivot point) that is connected tothe clip mount. In an example, the clip hinge 226 can allow the topsupport jaw 218 to move respective to the bottom support jaw 216, orvice versa. Alternatively, the clip hinge 226 can allow both the bottomsupport jaw 216 and the top support jaw 218 to move respective to oneanother.

In some embodiments, the top support jaw 218 and the bottom support jaw216 can be configured to pivot about the clip hinge 226, furtherdepicted and discussed in relation to FIG. 5C, such that the top supportjaw 218 and the bottom support jaw 216 can be opened or closed. In someembodiments, the top support jaw 218 and the bottom support jaw 216 canbe closed such that the bottom occlusion clip 212 contacts the topocclusion clip 214 and/or comes within a close proximity of the topocclusion clip 214. In some embodiments, the bottom occlusion clip 212and the top occlusion clip 214 can be closed such that when the atrialappendage is positioned between the bottom and top occlusion clips 212,214, the atrial appendage can be occluded when the bottom and topocclusion clips 212, 214 are closed (e.g., are configured to occlude theatrial appendage).

The clip catheter (e.g., flexible shaft 224) can pass through a centrallumen of the expansion catheter 210 from the occlusion device 204 to acontrol handle, in an example. In an undeployed state, the occlusiondevice 204 and the steerable expanding shroud 202 can be stored withinthe distal end of the outer sheath 208.

In some embodiments, as discussed in relation to FIG. 2A, the expansioncatheter system can include guidewires (e.g., top guidewire 228, bottomguidewire 230) to aid in deployment of the occlusion device 204. Forexample, one or more guidewires can pass from a proximal end of theouter sheath 208 and can be looped in the distal end of the outer sheath208 and can pass back to the proximal end of the outer sheath 208. Insome embodiments, a distal end of the guidewires can be connected nearthe distal end of the outer sheath 208. For example, the guidewires canbe connected to an inner wall of the distal end of the outer sheath 208.In an example, a top guide lumen 232 can be connected to the top supportjaw 218 and in some embodiments can be 90 degrees opposed to the topocclusion surface 220 of the top support jaw 218 or top occlusion clip214. For example, the top guide lumen 232 can be disposed along a sideof the top support jaw 218, such that a longitudinal axis formed by thetop guide lumen 232 is parallel with a longitudinal axis formed by thetop support jaw 218 and/or top occlusion clip 214. In addition, a bottomguide lumen 234 can be connected to the bottom support jaw 216 and insome embodiments can be 90 degrees opposed to the bottom occlusionsurface 222 of the bottom support jaw 216 or bottom occlusion clip 212.For example, the bottom guide lumen 234 can be disposed along a side ofthe bottom support jaw 216, such that a longitudinal axis formed by thebottom guide lumen 234 is parallel with a longitudinal axis formed bythe bottom support jaw 216 and/or bottom occlusion clip 212. In anexample, the guide lumens 232, 234 can be tubes, which can be hollowcylinders that are axially aligned with a longitudinal axis of eachrespective occlusion clip 212, 214 and/or support jaw 216, 218, asdiscussed herein.

In an example, a proximal end of each guidewire 228, 230 can be pusheddistally such that a distal end of each guidewire 228, 230 is pusheddistally with respect to the distal end of the outer sheath 208 suchthat a distal looped portion 236, 238 is disposed distally with respectto the distal sheath portion. In some embodiments, as depicted, a distalloop can be formed in each guidewires 228, 230, located distally withrespect to the distal end of the outer sheath 208. In an example, theguidewires 228, 230 can be formed from a flexible material and/or shapememory material (e.g., nitinol), which can be naturally biased, suchthat loops formed by each of the guidewires 228, 230 expand when theguidewires 228, 230 are pushed out of the distal end of the outer sheath208. For example, the guidewires 228, 230 can form loops that expandoutwardly from a longitudinal axis formed by the expansion catheter 210,thus providing guides for the top guide lumen 232 and the bottom guidelumen 234 to ride along.

In some embodiments, the clip catheter can be a flexible shaft 224,which can be constructed so the shaft has an internal tension and anouter compression. Upon deployment of the guidewires 228, 230, theocclusion device 204 can be deployed from the distal end of the outersheath 208 via the flexible shaft 224 (e.g., by pushing the flexibleshaft 224 distally with respect to the outer shaft 208 and can be guidedalong the guidewires 228, 230. In an example, the occlusion device 204can be turned as it follows the guidewires 228, 230 (e.g., is movedalong the guidewires) toward the distal loops of the guidewires 228,230, as depicted in FIG. 5B. For example, the occlusion device 204 canbe turned from a straight orientation, the straight orientation beingaligned with the sheath longitudinal axis, as the occlusion device ismoved distally along the first guidewire and about the distal loopedportion (e.g., distal looped portion 236). In some embodiments, thedistal looped portion and the occlusion device can be stored within thecentral lumen in an undeployed state and can be located distally withrespect to the distal sheath portion in a deployed state.

In some embodiments, a first guidewire (e.g., top guidewire 228) cancomprise a first guidewire end and a second guidewire end and a secondguidewire (e.g., bottom guidewire 230) can comprise a third guidewireend and a fourth guidewire end. The first and second guidewires canextend from their respective guidewire ends through the central lumenand can form a first guidewire distal looped portion 236 and a secondguidewire distal looped portion 238, respectively, as depicted. In someembodiments, the first and second guidewire distal looped portions 236,238 are stored within the central lumen in an undeployed state and thefirst and second guidewire distal looped portions 236, 238 areconfigured to expand outwardly (e.g., laterally) with respect to alongitudinal axis of the outer sheath 208 upon deployment from thedistal sheath portion.

In some embodiments, the guide lumens 232, 234 can each be aligned witha longitudinal axis of a respective one of the support jaws 216, 218. Insome embodiments, the first support jaw 216 can be configured to bemoved distally along the first guidewire and about the first guidewiredistal looped portion 236 and the second support jaw can be configuredto be moved distally along the second guidewire and about the seconddistal looped portion 238 in unison with the first support jaw. In someembodiments, the first support jaw 216 and the second support jaw 218can be turned from a straight orientation, the straight orientationbeing aligned with the sheath longitudinal axis, as the first supportjaw 216 and the second support jaw are moved distally along the firstand second guidewire and about the first and second distal loopedportions 236, 238.

In some embodiments, the bladder 192 can help stabilize and holdguidewires 228 and 230 in place against inside of shroud 186, ifsufficiently inflatable to fill the shroud after the clip 212 and 214 isadvanced outside the shroud. In some embodiments, this can help maintainan advantageous guidewire position.

FIG. 5B depicts the steerable expanding sheath 202, the occlusion device204 in a second deployed state, and the visualization device 206extending from the distal end of the outer sheath 208 comprising part ofthe expansion catheter 210, in accordance with embodiments of thepresent disclosure. In some embodiments, the endoscope can extendthrough the central lumen (e.g., of the outer sheath 208 and/or innersheath) from the proximal sheath portion to the distal sheath portion.As depicted in FIG. 5B, the endoscope 206 can also be moved distallywith respect to the expansion catheter 210 to enable a better view ofthe occlusion device 204 and/or surrounding tissue structures within thebody of the patient. As depicted, the occlusion device 204 can followthe guidewires 228, 230 as it is pushed distally with respect to thedistal end of the outer sheath 208. In some embodiments, the flexibleshaft 224 can bend to allow the occlusion device 204 to turn along thepath formed by the guidewires 228, 230. In some embodiments, theguidewires 228, 230 can have a rigidity, individually or in combinationwith one another, that is greater than a rigidity of the flexible shaft224, allowing for the flexible shaft 224 to bend instead of theguidewires 228, 230 as the occlusion device 204 is protracted and/orallowing for the flexible shaft 224 to bend more than the guidewires228, 230 as the occlusion device 204 is protracted.

FIG. 5C depicts a view from the visualization device 206 in FIG. 5B, inaccordance with embodiments of the present disclosure. As depicted, theview from the visualization device 206 (e.g., endoscope) shows theocclusion device 204, the guide lumens 232, 234, the guidewires 228,230, the steerable expanding shroud 202, as well as the flexible shaft224, which has been moved distally to deploy the occlusion device 204. Aview of the clip hinge 226, as well as a clip hinge pin 250 is depicted.The top support jaw 218 can be configured to rotate about the hinge pin250 and/or the bottom support jaw 216 can be configured to rotate aboutthe hinge pin 250 to enable closing of the occlusion device 204. In someembodiments, the clip advancing and opening controls 146, depicted inFIG. 2A, can be used to open and/or close the occlusion device 204. Inan example, the cable housing 150 and the cable 148 can extend throughthe flexible shaft 224. In some embodiments, a distal end of the cable148 can be attached to the bottom support jaw 216 and upon pulling thepull knob 149 proximally, the bottom support jaw 216 can be closedand/or moved closer in relation to the top support jaw 218 (e.g., thebottom occlusion clip 212 can be moved closer to the top occlusion clip214). In some embodiments, the guidewires 228, 230 can be biased inorder to open the occlusion device 204. Thus, the occlusion device 204can naturally remain in an open state unless a tension is applied to thecable 148 (e.g., via the pull knob).

FIG. 6A depicts the steerable expanding shroud 260, an ablation device262, and a visualization device 264 (e.g., endoscope) extending from adistal end of the expansion catheter 266 associated with the exemplaryexpansion catheter system in FIG. 1, in accordance with embodiments ofthe present disclosure. In some embodiments, an elongated suctionablation device 262, such as the COBRA Fusion® device can be deployedfrom the distal end of the expansion catheter 266. The elongated suctionablation device 262 can operate by creating a vacuum in a trough 270 ofthe suction body 268 that draws tissue into the trough 270, which islined with electrodes. Power can be applied to the electrodes and usedto ablate tissue, ensuring transmurality. The suction can also be usedto hold the device in a desired location. In an example, the elongatedsuction ablation device 262 can be attached to a shaft that extendsthrough the expansion catheter 266 and is connected to the elongatedsuction ablation device 262 via a manipulatable joint 272. In someembodiments, the manipulatable joint 272 can be robotic and controlledfrom the catheter handle and/or via another mechanical and/or electronicdevice in communication with the manipulatable joint 272.

In some embodiments, the elongated suction ablation device 262 can bedeployed from the expansion catheter 266 by moving the shaft 274associated with the device 262 distally along the expansion catheter. Inaddition, an endoscope can be deployed from the expansion catheter. Inan example, the endoscope can include an inflatable bladder 276, asdiscussed in relation to FIG. 4. As depicted in FIG. 6A, the inflatablebladder 276 is in a deflated state. In an example, when the endoscope264 is stored in the expansion catheter 266, the inflatable bladder 276can be deflated.

FIG. 6B depicts a view from the visualization device 264 in FIG. 6A, inaccordance with embodiments of the present disclosure. As depicted, aview from the visualization device 264 shows the elongated suctionablation device 262, the manipulatable joint 272, as well as thesteerable expanding shroud 260. In some embodiments, the manipulatablejoint 272 can be rotated, such that the elongated suction ablationdevice 262 can be rotated about a longitudinal axis formed by the shaft274. In some embodiments, the manipulatable joint 272 can be a universaljoint, allowing for deflection and/or torque transmission (e.g., roll)of the elongated suction ablation device 262 with respect to the shaft274.

FIG. 6C depicts an elongated suction ablation device 290, in accordancewith embodiments of the present disclosure. In some embodiments, theelongated suction ablation device 290 can include a shaft 292, which canbe flexible, semi-rigid, and/or steerable. The suction body 294 can besimilar to the one depicted in FIG. 6A. The shaft 292 can be connectedto an elongated suction body 294, which can be similar to the COBRAFusion® device, without a magnet and/or tether located at a distal endof the suction body 294. Alternatively, in some embodiments, the distalend of the suction body 294 can include a magnet and/or tether. In someembodiments, an axial length of the suction body 294 can beapproximately 25 millimeters, although dimensions are not so limited andthe axial length of the suction body can be larger or smaller.

In some embodiments, a dorsal guidewire lumen 296 can extend dorsallyalong the suction body 294. In some embodiments, one or more lateralguidewire lumens can be disposed alongside the suction body. Forexample, a pair of lateral guidewire lumens can be disposed alongsidethe suction body and can be diametrically opposed to one another. Theguidewire lumen 294 can be a tube through which a guidewire can pass ina manner similar to that discussed and depicted in relation to guidelumens 232, 234 in FIGS. 5A-5D. For example, the suction body 294 can bepushed from the distal end of the expansion catheter into a spacecreated by the steerable expansion sheath and can be guided in placealong the guidewire passing through the guide lumen.

FIG. 6D represents a stylized representation of a view from avisualization device showing an elongated suction ablation device,similar to the one shown in FIG. 6C, being guided along a guidewire 302inside of a lumen 304, in accordance with embodiments of the presentdisclosure. In an example, the suction body 300 of the elongated suctiondevice is shown contacting or about to contact tissue 306 to perform anablation. The suction body 300 can include the guide lumen (not shown)mounted dorsally along the suction body, as depicted in FIG. 6C. Theguidewire 302 can extend through the guide lumen and can form a distalloop, as discussed herein. As the suction body 300 is advanced by acombination of pushing and/or pulling on the guidewire 302 and/orpushing and/or pulling on the shaft connected to the suction body 300,the dorsal guide lumen can move along the guidewire 302 causing thesuction body 300 to be positioned in a particular manner, as discussedand depicted in relation to FIGS. 5A-5D.

FIG. 7 depicts an isometric side and front view of a visualization,pacing, sensing, and/or ablation device (hereinafter device 320), inaccordance with embodiments of the present disclosure. In someembodiments, the device 320 can include a sheath and a mount 324, towhich a sealed cap 326 can be attached. In some embodiments, the sealedcap 326 can be attached to a recessed cap mounting lip 338circumferentially extending around an exterior of the mount 324. In anexample, the sheath 322 can be connected to the mount 324. In someembodiments, an endoscope 328 can be inserted into and extend through alumen defined by the sheath 322. The endoscope 328 can be steerable, insome embodiments. In an example, the endoscope 328 can be slid distallyfrom the position it is shown in FIG. 7, such that the endoscope 328 isplaced within the sealed cap 326 and can be steered within the sealedcap 326 to view different area.

In some embodiments, the sealed cap 326 can create a space between theendoscope 328 and the tissue to improve visualization. In someembodiments, the sealed cap 326 can protect the endoscope 328 fromfluids to enable a clear view from the endoscope 328. The sealed cap 326can make ablation more effective and enhance the view with furtherseparation from target tissue while still minimizing a profile of thedevice 320.

In some embodiments, the mount 324 can include a port 332 for theendoscope 328 to pass through. In an example, a distal end of the port332 can include one or more axial relief cuts 330 made around acircumference of the port 332, which can extend parallel with alongitudinal axis extending through the port 332. The one or more reliefcuts 330 can allow a distal rim of the port 332 to flex when theendoscope 328 is placed in the port 332. Flexing of a distal rim of theport 332 via the relief cuts when the endoscope 328 is placed throughthe port 338 can create a frictional force between the endoscope 328 andthe distal rim of the port 332, thus keeping the endoscope 328 in place,within the port 332, and preventing the endoscope 328 from beingaccidentally shifted.

In some embodiments, the mount 324 can include a proximal outer lip, towhich a flexible torqueable sheath can be connected (e.g., slid over).The flexible torqueable sheath can be passively flexible, such that itcan deflect when the endoscope 328 is deflected, as further discussedherein. For example, the sealed cap 326 can be provided with four-waysteerability.

In some embodiments, an irrigation lumen can be in fluid communicationwith the sealed cap, such that the sealed cap 326 can be filled with afluid (e.g., liquid, gas). In an example, liquid can be introduced intothe sealed cap 326 and can fill the sealed cap 326 to reduce a glareproduced on an inner surface of the sealed cap 326. The fluid can beexpelled from a distal tip hole 336 and/or other holes formed in thesealed cap 326 to provide irrigation.

In some embodiments, electrodes 340-1, 340-2, 340-3 can be disposed onan outside of the sealed cap 326. In an example, an electrode shaft 342can include ring electrodes 340-1, 340-2, 340-3 spaced apart between adistal tip of the electrode shaft 342 and a proximal end of theelectrode shaft 342. In some embodiments, as depicted, the electrodeshaft 342 can extend parallel, but off-axis with respect to alongitudinal axis extending through the sealed cap 326. The ringelectrodes 340-1, 340-2, 340-3 can be separated from one another via aninsulating material and can be used for ablation, sensing, and/orpacing. The distal end of the electrode shaft 342 can include a tipelectrode 344 in some embodiments, which can be used for ablation,sensing, and/or pacing.

In some embodiments, the device 320 and/or the sealed cap 326 can bemade from a rigid, semi-rigid, flexible, and/or elastic material that istranslucent and/or semi-translucent, such that the endoscope 328 canlook through the sealed cap. In some embodiments, an axial groove can bedisposed in an outer surface of the sealed cap 326 that extendsparallel, but off axis with respect to a longitudinal axis extendingthrough the sealed cap 326. In an example, the electrode shaft 342 canbe placed within the axial groove, as discussed herein.

In some embodiments, the sealed cap 326 can be inflated and/or deflatedthrough introduction of a fluid into the sealed cap 326. Inflation ordeflation of the sealed cap 326 can allow for the sealed cap 326 to moreeasily fit into a distal end of an expansion catheter and/or be moreeasily introduced into various cavities of the body. Upon deployment ofthe sealed cap 326 from the expanded catheter, for example, the sealedcap 326 can be inflated from a deflated and/or partially deflated state.

FIG. 8A depicts a side view of the visualization, pacing, sensing,and/or ablation device 362 similar to that depicted in FIG. 7 attachedto a distal end of a catheter 360, in accordance with embodiments of thepresent disclosure. The device 362 can include a mount 364, endoscope(not depicted), and/or sealed cap 368, as discussed in relation to thedevice in FIG. 7. The device 362 can be attached to a distal end of acatheter 360, as shown in FIG. 8. In some embodiments, the catheter 360can include different materials such that different portions of thecatheter 360 can have a different flexibility. For example, distal andproximal portions of the catheter 370-1, 370-3 can be less flexible thanan intermediate portion 370-2 of the catheter 360. In some embodiments,the distal and proximal portions of the catheter 370-1, 370-3 can be ashrink wrap that is applied to an outer surface of the catheter. Thiscan allow the intermediate portion of the catheter 370-2 to be moreflexible, thereby allowing for an increased flexibility associated withthat portion of the catheter.

In some embodiments, the device 362 can include a first electrode shaft372-1 and a second electrode shaft 372-2 that contain one or moreablation, sensing, and/or pacing electrodes. As discussed in relation toFIGS. 7, 10A, and 10B, the sealed cap 368 can include an axial groovedisposed along the outside of the sealed cap 368 for the first electrodeshaft 372-1 and the second electrode shaft 372-2. The first and secondelectrode shafts 372-1, 372-2 can be placed in each respective axialgroove.

FIG. 8B depicts a cross section of the catheter shown in FIG. 8A, inaccordance with embodiments of the present disclosure. In someembodiments, an endoscope cable 374 can pass through a central lumen ofa sheath 376, which is depicted in FIG. 7. The endoscope cable 374 canbe passively flexible, in some embodiments, and the sheath 376 caninclude pull wires, which can be selectively tensioned to deflect thesheath 376. Alternatively, the endoscope cable 374 can be deflectableand the sheath 376 can be passively flexible. In some embodiments, thesheath 376 can be inserted into a lumen defined by the proximal lip 334,but not connected to the mount, shown in FIG. 7. In some embodiments, aflexible torqueable sheath 378 can be coaxial with the sheath 376, suchthat the sheath 376 passes through a center of the flexible torqueablesheath 378. In an example, the flexible torqueable sheath 378 can beconnected to an outer face of the proximal lip 334 and can be rotatablewith respect to the sheath 376 and the endoscope. As such, the flexibletorqueable sheath 378 can be rotated, thus rotating the mount 364 andthe sealed cap 368 with respect to the endoscope, and the sheath 376.Thus, the electrode shafts 372-1, 372-2 disposed on the outside of thesealed cap 368 can be rotated to a particular position. In someembodiments, the endoscope can also be rotated to orient the endoscopein such a way that a display generated by the endoscope appears in aproper orientation (e.g., right side up).

FIG. 9 depicts a stylized representation of a view from an endoscopewithin the visualization, pacing, sensing, and/or ablation device inFIG. 7, in accordance with embodiments of the present disclosure. In anexample, the view can be from the endoscope placed with the sealed cap326. The view from the endoscope can overlook the electrode shaft 342′that contains electrodes 340-1′, 340-2′, 340-3′ and also overlook thetissue that has been ablated or will be ablated. As depicted, theablation lines have been created via a tip electrode 344 located at adistal tip of the electrode shaft 342. In some embodiments, theendoscope can be used to provide a view when navigating the device 320into position to perform an ablation, sensing, and/or pacing procedure.

FIG. 10A depicts an isometric side and bottom view of a visualization,pacing, sensing, and/or ablation device 388, in accordance withembodiments of the present disclosure. In some embodiments, a proximalend of a sealed cap 396 can be connected to a distal end of a shaft 398.As depicted, the sealed cap 396, as previously discussed, can includegrooves formed in a bottom of the sealed cap 396, in which electrodeshafts can be placed. The electrode shafts 392-1, 392-2 can includeelectrodes 394-1, 394-2, 394-3, 394-4 for ablation, sensing, and/orpacing, in some embodiments. In some embodiments, the device 388 cancomprise two or more electrodes, which can be used for bi-polar ablationof tissue. In some embodiments, material forming the bottom of thesealed cap 396 (e.g., portion of the sealed cap in which the grooves areformed) can be thicker than in other portions of the sealed cap toprovide support for the electrode shafts 392-1, 392-2 and more easilyallow the grooves to be formed, as shown in relation to FIG. 11A.

FIG. 10B depicts a bottom view of the visualization, pacing, sensing,and/or ablation device 388 depicted in FIG. 10A, in accordance withembodiments of the present disclosure. As depicted, the electrode shafts392-1, 392-2 can extend axially along the bottom of the sealed cap 396.As discussed herein, the sealed cap 396 can be formed of a translucentand/or semi-translucent material so the endoscope can provide an imagethrough the sealed cap 396.

FIG. 11A depicts a side view of a visualization, pacing, sensing, and/orablation device 410, in accordance with embodiments of the presentdisclosure. In an example, the device 410 can include the sealed cap, asdiscussed herein. In some embodiments, a bottom portion 414 of thesealed cap 412 can include a thicker walled material than some otherportions of the sealed cap 412. As depicted, the bottom portion 414 canbe thick walled and other portions can be thin walled. In someembodiments, the electrode shafts 416 can be connected to the thickwalled bottom portion 414.

In some embodiments, the bottom portion can be formed of a substratethat is different than thin walled portions 418. For example, thesubstrate can be a translucent material that is formed from a semi-rigidand/or rigid material, while some other portions of the sealed cap 412(e.g., thin walled portions 418) can be formed of a flexible or elasticmaterial. In an example, only a portion of the sealed cap 412 thathouses the electrode shafts 416 with a reasonable margin is comprised ofa rigid optically clear polymer. The remainder of the sealed cap 412 canbe comprised of an expandable member such as a woven wire frame oroptionally a balloon, bonded to the rigid element to provide anexpansion means, discussed herein. If a balloon is used, the balloon canbe separated from the rigid ablation element to avoid issues ofheat/cold affecting the balloon's integrity. For example, a balloon canbe connected to the substrate, such that the balloon can be inflatedand/or deflated to reduce a size of the sealed cap 412 for introductioninto the body of a patient. In an example, the device 410 can be reducedto a size that would fit into a 4/10 millimeter cannula. As furtherdepicted, a sheath 420 can be connected to the proximal end of thesealed cap 412 and a wire can provide electricity to the electrodes onthe electrode shafts 416. In some embodiments, the sheath 420 caninclude pull wires for steering the sheath 420. The pull wires, in someembodiments, can also provide electricity to the electrodes or othercomponents associated with the sealed cap 412. In addition, an endoscopecan be included in the sealed cap 412, as discussed herein. A view fromthe endoscope can be of an area where an ablation or other procedure isbeing performed. A cable associated with the endoscope can pass throughan opening 424 in the sheath 420 to provide connectivity with theendoscope.

In some embodiments, as discussed herein, ablation elements disposed onan outside of the sealed cap 412 can be electrodes. Ablation elementscan be configured as an RF-electrode, cryo-electrode, bipolar RF shaft,or a vacuum trough with opposing electrodes, such as those associatedwith the COBRA Fusion® device.

FIG. 11B depicts a front view of the visualization, pacing, sensing,and/or ablation device 410 depicted in FIG. 11A, in accordance withembodiments of the present disclosure. In some embodiments, a fluidlumen can pass through the shaft 420 associated with the sealed cap 412and can be used to introduce a fluid into the sealed cap 412 to inflatethe sealed cap 412 and/or reduce a glare within the sealed cap 412and/or visual distortion that arises from the air to polymer interfaceof the inner surface within. In an example, the fluid can be a gas suchas carbon dioxide and/or a liquid such as saline. In some embodiments,fluid entering the sealed cap from the fluid lumen 430 can pass throughthe distal tip hole 432 in the sealed cap such that irrigation fluid canbe provided to a therapy site and/or gas can be provide to a therapysite for insufflation.

FIG. 12A depicts a front view of an alternate embodiment of thevisualization, pacing, sensing, and/or ablation device in FIG. 11B witha hinge 448 and in a folded state, in accordance with embodiments of thepresent disclosure. In some embodiments, the sealed cap can include ahinge 448 that extends axially along a bottom of the sealed cap. In anexample, the hinge can extend between the two electrode shafts 440-1,440-2 and can be connected to the substrate 442 that forms the bottom ofthe sealed cap. In an example, the substrate 442 can be a semi-rigidand/or rigid material and the hinge 448 can axially divide the substrate442 in half, such that the substrate 442 can be folded in half In anexample, a flexible material 444 can be connected to a perimeter of thesubstrate 442 and the pieces of the substrate 442 that are divided bythe hinge can be folded toward the flexible material (e.g., upward) tocollapse the sealed cap and flexible material and reduce its size, asshown in FIG. 12A.

FIG. 12B depicts a front view of the visualization, pacing, sensing,and/or ablation device in FIG. 12A in an opened and partially expandedstate, in accordance with embodiments of the present disclosure. In anexample, the device in FIG. 12A can be unfolded about the hinge 448, asillustrated in FIG. 12B. As depicted, a joint can be seen runningthrough the substrate between the electrodes in FIG. 12B at which thehinge 448 can be placed. In some embodiments, the hinge 448 can be asealed hinge, such that fluid does not leak from an inner space of thesealed cap through the hinge 448. The flexible material 444 can be seenin a partially expanded state draped across a top of the substrate 442and connected to the perimeter of the substrate 442.

FIG. 12C depicts a front view of the visualization, pacing, sensing,and/or ablation device in FIG. 12A in an opened and expanded state, inaccordance with embodiments of the present disclosure. As depicted, afluid can be introduced into the sealed cap and the fluid can cause theflexible material 444 to be expanded and inflated to a particular size.The device can have an inflated diameter in some embodiments of 1 to 3centimeters.

FIG. 13A depicts an isometric front and side view of a portal accessdevice in a retracted state, in accordance with embodiments of thepresent disclosure. In an example, the portal access device 460 can beused in relation with embodiments discussed herein to provide an accesspathway into a space within the body. In an example, the portal accessdevice 460 can include a manifold 462 at a proximal end of the portalaccess device 460. The manifold can include a suction tube 464, as shownin FIG. 13A. A distal end of the manifold 462 can be connected to aproximal end of a central cannula 466. The central cannula 466 cancomprise a central lumen 468 that runs through a center of the centralcannula 466. In some embodiments, the central lumen 468 can extendthrough the manifold 462, such that an instrument can be insertedthrough a proximal end of the manifold 462 distally through the centrallumen 468.

In some embodiments, a coupling ring 470 can be connected to a distalend of the central cannula 466. In some embodiments, the coupling ring470 can have a larger diameter than the central cannula 466. In someembodiments, the coupling ring 470 can include hooks positioned around adistal inner perimeter (e.g., distal face) of the coupling ring 470, asdepicted in FIG. 13A. In an example, the hooks 472 can be housed in hookhousings 474 formed in a distal face of the coupling ring 470. A numberof hook pin bores 476 can be formed in an outer surface of the couplingring 470. In an example, a pin can be driven into the hook pin bore 476for each hook 472 and through an opening in each hook 472 to hold thehook 472 in place and allow the hook 472 to rotate about the pin. Insome embodiments, hook pin bore 476 can be associated with a hook pinhole for hook 472.

In some embodiments, a distal face of the coupling ring 470 can includea plurality of suction ports 478 spaced around the distal face of thecoupling ring 470. In an example, a suction lumen can extend proximally(e.g., through a wall of the central cannula) from each of the suctionports 478 to the manifold 462 and to the suction tube 464. As such, thesuction tube 464 can be in fluid communication with each of the suctionports 478 located on the face of the coupling ring 470. In someexamples, each of the suction ports 478 can include a suction rib 480that extends in a radial direction from the central lumen 468. In anexample, the suction rib 480 can extend across each suction port 478 toprevent tissue from being sucked into the suction port 478. Forinstance, the tissue can be draped over the suction port 478, exposingadditional surface area of the tissue to the suction drawn through thesuction port 478. Thus, a greater suction force can be applied to thetissue with use of the suction rib 480 and/or prevent damage to thetissue caused by the tissue being drawn into the suction port 478.

In some embodiments, the proximal end of the portal access device 460can be introduced into a patient's chest. The coupling ring 470 can beplaced in contact with the pericardium. Once the coupling ring 470contacts the pericardium, a suction can be drawn through the suctiontube 464, thus creating an applied suction at each one of the suctionports 478. The tissue of the pericardium can be sucked into each one ofthe suction ports 478 and can thus be drawn against the coupling ring470. With the pericardium in close relation to the proximal surface ofthe coupling ring 470 due to the suction force applied to the tissue viaeach one of the suction ports 478, the pericardium can be lifted fromthe myocardium, in some embodiments. In some embodiments, suction canalso be applied in the central lumen 468, which can provide an increasedsuctional force for lifting the pericardium from the myocardium. In someembodiments, the suction tube can be in fluid communication with thecentral lumen 468 and/or an additional lumen suction tube can be influid communication with the central lumen 468, which can be used toapply suction to the central lumen 468. The hooks 472 can be deployed topenetrate the pericardium and hold it in close relation to the proximalend of the coupling ring 470, as further depicted in the followingfigures.

In an example, the portal access device 460 can be used to introduce aninstrument into the interstitial space between the pericardium and themyocardium. In some embodiments, the portal access device 460 can beused to introduce any one of the devices disclosed in the presentdisclosure into an interstitial space between the pericardium and themyocardium, as further discussed herein.

FIG. 13B depicts a front view of the portal access device 460 in FIG.13A in the retracted state, in accordance with embodiments of thepresent disclosure. As depicted, the portal access device 460 includesthe coupling ring that has suction ports 478 dispersed around a distalface of the coupling ring 470. In some embodiments, the hook housings474 can be formed between the suction ports 478 to hold the hooks 472.In addition, the suction ports 478 can include the suction ribs 480, asdiscussed herein, which can extend in a radial direction radially fromthe central lumen 468. Alternatively, the suction ribs 480 can extendacross the suction ports 478 in a direction that is tangential to thecylindrical coupling ring 470. In some embodiments, a screen can beplaced over each of the suction ports 478 to prevent tissue from beingsucked into the suction port 478.

FIG. 13C depicts a cross-sectional side view of the portal access device460 in FIG. 13B along line E-E in a retracted state, in accordance withembodiments of the present disclosure. As depicted, the portal accessdevice 460 includes the coupling ring 470 attached to the distal end ofthe central cannula 466. The cross-sectional view depicts the hooks 472in a retracted state. Each hook 472 can include a control rod attachmentpoint 490 disposed on an opposite side of a hook pin hole 492. A hookpin 494 can be placed in the hook pin hole 492 via a corresponding hookpin bore 476 to hold the hook pin 494 in place and create a fulcrumpoint for the hook 472 to rotate about. The control rod attachment point490 can include a hook fulcrum pin hole 496, through which a control rodpin 498 can pass through to connect a control rod 502 to the hook 472.The control rod 502 can pass through a control rod lumen 506 to the pullring 482.

In some embodiments, the control rod 502 can extend all the way throughthe control rod lumen 506 to the pull ring 482. Alternatively, a pullwire can connect the control rod 502 to the pull ring 482. Moving thepull ring 482 distally or proximally can move the control rod 502distally or proximally, such that the control rod 502 can rotate thecontrol rod attachment point 490 and the hook 472 about the hook pin494. As such, the hook 472 can be retracted or engaged via movement ofthe pull ring 482. In some embodiments, the control rod 502 can beconnected to another type of device, such as a joy stick, for example.In some embodiments, the coupling ring 470 can include a fulcrum channel504, as depicted, to allow space for the control rod attachment point490 to move.

As further depicted, the coupling ring 470 includes the suction port 478and the suction rib 480 located in the proximal face of the couplingring. In some embodiments, the distal face of the coupling ring can becontoured from a most distal outer perimeter towards a center of thecentral lumen. For example, the proximal face can be curved (e.g.,radiused), as illustrated.

FIG. 13D depicts the cross-sectional side view of the portal accessdevice in FIG. 13C in a penetrating state, in accordance withembodiments of the present disclosure. As depicted, the control rod 502has been moved proximally toward the control rod lumen 506, thusrotating the hook fulcrum proximally in the fulcrum channel 504, which,in turn has rotated the hook 472 distally towards the distal end of thecoupling ring 470 into a penetrating state.

FIG. 13E depicts the cross-sectional side view of the portal accessdevice 460 in FIG. 13C in an engaged state, in accordance withembodiments of the present disclosure. As depicted, the control rod 502has been moved further proximally toward the control rod lumen 506, morefully rotating the control rod attachment point 490 towards a proximalend of the portal access device 460, which, in turn has rotated the hookdistally towards the distal end of the coupling ring 470 into an engagedstate.

In some embodiments, when the hook 472 is in a penetrating state,grasping the pericardium, the tip of the hook 472 can be configured inrelation to the coupling ring 470 to not pass the most distal end of thecoupling ring 470. This can be to prevent accidental grasping of themyocardium, in some examples. Through use of the suction ports 478, thepericardium can be sucked into reach of the hooks 472, and the hooks 472can grasp the pericardium. This can further prevent accidental graspingof the myocardium with the hooks 472, since the pericardium can besucked into reach of the hooks 472 and in some embodiments pulled fromthe myocardium, separating the hooks 472 from the myocardium.

FIG. 13F depicts an isometric front and side view of the portal accessdevice 460 in FIG. 13A in an engaged state, in accordance withembodiments of the present disclosure. As depicted, the hook 472 can beretracted into the hook housing 474. In some embodiments, the portalaccess device 460 can be configured to be inserted into the patientusing a subxiphoid approach and the coupling ring 470 can be placed intocontact with the pericardium via suction, as discussed herein.Alternatively, the portal access device 460 can be attached to thepericardium proper. In some embodiments, the coupling ring 470 can beplaced in contact with the apex of the heart. As discussed herein, thepericardium can be suctioned to the coupling ring 470 via the suctionports, the hooks 472 can be engaged to hook and retain the pericardium,and the suction can be turned off.

In some embodiments, the pericardium can be incised with a blade orcautery inserted down the central lumen 468 of the portal access device460 to create an access port into the interstitial space through thepericardium. In some embodiments, a lumen can extend through a proximalend of the manifold 462 and can be in communication with the centrallumen 468. As such, a continuous lumen can pass through the portalaccess device 460 from a proximal end to a distal end. In someembodiments, the lumen in the manifold 462 can include a seal, throughwhich an instrument can be passed through. For example, a layer ofsilicon material can be placed across the lumen in the manifold 462 thatincludes a hole through which an instrument can be passed. As aninstrument is inserted in the hole, the silicon can expand and sealaround the instrument to prevent any fluid or gas from exiting themanifold 462 of the portal axis device.

In some embodiments, the portal access device can include aninsufflation tube that is in communication with the central lumen 468.In an example, when the portal access device 460 has been attached tothe pericardium via the hooks 472, an insufflation gas and/or liquid canbe pumped in through the insufflation tube and down the central lumen468 and into the interstitial space in the pericardium. In someembodiments, a flexible seal can be placed around a proximal end of thehook housing 474, which can make contact with the pericardium and helpcreate a seal such that leakage of the insufflation gas and/or liquidcan be minimized from the interface between the coupling ring 470 andthe pericardium.

In some embodiments, a pair of inflatable rings can be deployed from thecoupling ring 470 and/or from a portion of the portal access device 460adjacent to the coupling ring 470. In an example, an inflatable ringcould be deployed within the pericardial sac and a second inflatablering could be deployed external to the pericardial sac. In an example,the pericardium can be sandwiched by the inflatable rings to help createa seal, such that leakage of the insufflation fluid from between theinterface of the coupling ring 470 and the pericardium can be minimized.

In some embodiments the portal access device 460 can include an integralendoscope. The integral endoscope can be placed with the central lumen468, along one side of the central lumen 468 and/or can be placed withina distal end of the coupling ring 470, in some embodiments.

FIGS. 14A to 14C depict various embodiments of the portal access device,in accordance with embodiments of the present disclosure. FIG. 14Adepicts an exemplary representation of the portal access device shown inFIG. 13A, including the coupling ring 520, the central cannula 522,control rods 524 for actuating the hooks in the coupling ring 520, andthe pull ring 526. In an example, the pull ring 526 can be pulled in aproximal direction and/or pushed in a distal direction (e.g., retracted,protracted) such that each of the control rods are moved equally.Alternatively, the pull ring 526 can be rocked to move the control rodsdifferentially. As such, some of the hooks can be moved a greater amountthan or sequentially in relation to other hooks.

FIG. 14B depicts another embodiment of the portal access deviceincluding an angled coupling ring 540, which is further illustrated inFIGS. 14D and 14E. The portal access device in FIG. 14B includes acentral cannula 542, manifold 544, and suction tube 546, as previouslydiscussed. Due to the angle formed on the angled coupling ring, hooksmay not be employed on the angled coupling ring and the device depictedin FIG. 14B may be a suction device. In some embodiments, larger suctionports may be included in the angled coupling ring 540 and/or a sealingdevice, as discussed previously, may be used on the angled coupling ring540 to prevent leakage of insufflation fluid from between an interfacebetween the pericardium and the angled coupling ring. Further aspects ofthe embodiments depicted in FIG. 14B are discussed and depicted inrelation to FIGS. 14D to 14F.

FIG. 14C depicts another embodiment of the portal access device thatincludes a central cannula 550, a suction tube 554, and a manifold 552.The coupling ring 548 of the portal access device depicted in FIG. 14Cdoes not include hooks, but otherwise employs the suction ports,depicted in FIG. 13A, for example. In some embodiments, the suctionports associated with the embodiments in FIGS. 14B and 14A can be largerin size to provide a greater suction force to lift the pericardium fromthe myocardium and may or may not include screens and/or suction ribs.Further aspects of the embodiments depicted in FIG. 14C are discussedand depicted in relation to FIGS. 14D to 14F.

FIG. 14 D depicts an isometric side and front view of the distal end ofthe portal access 570 device in FIG. 14B, in accordance with embodimentsof the present disclosure. As depicted, the angled coupling ring 574 canbe attached to a distal end of the central cannula 572 and can includean angled distal end that includes a plurality of suction ports 576formed around the distal opening of the angled coupling ring 574. Insome embodiments, a distal face of the angled coupling ring 574 can beformed at an angle with respect to the central cannula. In someembodiments, this angle can be in a range from 1 degree to 75 degrees,10 degrees to 65 degrees, 20 degrees to 55 degrees, 30 to 50 degrees,and/or 35 to 45 degrees, although other ranges of angles are possible.In some embodiments, the distal face of the angled coupling ring 574 canbe angled and/or radiused towards the central lumen 578. For example, asurface of the distal face of the angled coupling ring 574 disposedbetween a distal outer perimeter of the angled coupling ring 574 and aninner perimeter of the angled coupling ring 574 can be angled towards aproximal end of the portal access device. The angled coupling ring canbe connected with the distal end of the central cannula.

As further depicted in FIG. 14D, each of the suction ports 576 can beflared open towards a distal end of the angled coupling ring 574. Insome embodiments, the suction ports 576 can be equally spaced around thecentral lumen 578 on a distal surface of the angled coupling ring 574.In some embodiments, the coupling ring 574 can include from 5 to 30, 10to 25, or 15 to 20 suction ports 576, although fewer than 5 or greaterthan 30 suction ports 576 can be included in the coupling ring 574. Asdepicted, the coupling ring 574 includes 17 suction ports 576. In someembodiments, a suction ridge 580 can be formed between adjacent suctionports 576. In an example, a width (e.g., circumferential width) of thesuction ridges 580 can be minimized such that suction is applied acrossa greater surface area of the pericardium. In some embodiments, thesuction ridge 580 can be radiused such that as the pericardium is drawnagainst the distal surface of the angled coupling ring, the pericardiumis not cut by the suction ridge 580.

FIG. 14 E depicts a diagrammatic side view of the distal end of theportal access device in FIG. 14B, in accordance with embodiments of thepresent disclosure. As depicted, the angled coupling ring 574 can have aplurality of suction ports 576 disposed around the distal opening of theangled coupling ring 574. The suction ports can be in fluidcommunication with suction lumens traveling through a wall of thecentral cannula. For example, suction port 576 can be in fluidcommunication with suction lumen 578, which can be disposed in an innerwall of the central cannula 572. The suction lumens can be in fluidcommunication with the suction tube, as previously discussed.

In some embodiments, the suction lumens 578 can be disposed in a wall ofthe central cannula 572 and the number of suction lumens 578 can equalthe number of suction ports. In some embodiments, the central cannulacan include one suction lumen and the angled coupling ring 574 caninclude a manifold that connects each of the suction ports to the onesuction lumen. As shown, the angled distal end of the coupling ring 754can have a curved shape to facilitate an intimate and tangential fitwith the surface of the heart (e.g., apex of the heart), in someembodiments. For example, the distal face of the coupling ring 754 canbe curved inward towards a proximal end of the portal access device 570between a distal tip 580 of the angled coupling ring and a distal baseof the angled coupling ring 582, as depicted in FIG. 14E. In someembodiments, the distal face of the coupling ring 754 can beperpendicular to a longitudinal axis formed by the central cannula 572,as depicted in FIG. 14C.

FIG. 14F depicts an isometric side view of a proximal end of the portalaccess device in FIG. 13A to 14F, in accordance with embodiments of thepresent disclosure. In an example, the portal axis device includes thecentral cannula 572, to which the manifold 594 is attached to a proximalend. The manifold 594 includes a suction tube 598, which defines asuction tube lumen 596 that is in fluid communication with a suctionmanifold ring 590 that extends around a circumference of the manifold594 and is coaxial with an axis extending through the manifold 594 andthe central cannula 572. The suction manifold ring 590 is in fluidcommunication with a plurality of suction lumens 578, which are in fluidcommunication with the suction ports 576 located at the distal end ofthe portal access device, as discussed herein. As such, the suction tubelumen 596 is in fluid communication with the suction ports 576. Thesuction manifold ring 590 can distribute the suction applied through thesuction tube lumen 596 substantially equally to the suction ports 576via the suction manifold ring 590. In some embodiments, the suctionmanifold ring can be formed in a distal base of the central cannulaand/or in a proximal end of the coupling ring, allowing for one or moresuction lumens to be disposed in the central cannula, which are in fluidcommunication with the suction tube lumen 596. In some embodiments,although the suction manifold ring 590 is depicted as a ring shapedlumen, with a circular cross-section, the manifold ring can have atriangular, square, or other shaped cross-section, in some embodiments.

In some embodiments, the manifold ring 590 can be coaxial with alongitudinal axis defined by the portal axis device. The suction lumenscan extend parallel to the longitudinal axis, in some embodiments, andcan intersect with a distal portion of the manifold ring 590. In someembodiments, the central cannula associated with embodiments depicted inFIGS. 13A to 14 F can be flexible and/or have a fixed curve associatedtherewith, in some embodiments.

The manifold includes a manifold hole, through which various devices canbe inserted. In an example, as discussed herein, the manifold hole caninclude a seal that can prevent or minimize leakage of fluids from themanifold hole.

FIG. 15A is an isometric side and front view of an access propagationdevice 610 in accordance with embodiments of the present disclosure. Theaccess propagation device 610 can be similar to a Lumitip™ dissectionsystem, produced by AtriCure. The access propagation device can be usedin conjunction with access tape 620, depicted in FIG. 15B. The accesstape 620 can have a distal pocket 622 into which a distal tip 624 of theaccess propagation device 610 can be inserted. For example, the accesstape 620 can have a top layer 626 and a bottom layer 628. In an example,a slit can be formed in the top layer 626 of the access tape 620 to forman insertion port 630 into the distal pocket 622. In some embodiments,the distal end of the distal pocket can be formed by sealing the edgesof the top layer 626 and the bottom layer 628 together to form a distalport 632 in the access tape 620.

In some embodiments, corners of the distal end of the distal pocket canbe sealed to form sealed edges 634-1, 634-2. In some embodiments, theaccess tape can include a hollow cylindrical magnet 636 inserted intothe distal pocket 622, as shown. In some embodiments, as depicted, thehollow cylindrical magnet 636 can be inserted along a longitudinal axisformed by the distal pocket 622, such that a longitudinal axis of themagnet 636 is generally aligned with the longitudinal axis formed by thedistal pocket 622. In some embodiments, the distal tip 624 of the accesspropagation device 610 can be inserted through the insertion port 630,into the distal pocket 622, and into the magnet. In an example, theaccess propagation device 610 can include a light at the end of thedistal tip 624, which can be used for navigation of the accesspropagation device 610. When the distal tip 624 is inserted into thedistal pocket 622 and into the magnet 636, the light from the distal tip624 can shine through the magnet 636 and out of the distal port 632. Assuch, by including a hollow cylindrical magnet 636 in the distal pocket622 and by forming the distal port 632, a light disposed on the distaltip 624 of the access propagation device 610 can shine through thedistal port 632, providing light for navigation and/or for retrieval bythe access retrieval device 650.

FIG. 16 is an isometric bottom view of an access retrieval device 650that includes an endoscope hood 654, in accordance with embodiments ofthe present disclosure. The access retrieval device 650 can include ashaft 658 that has a lumen extending there through. In some embodiments,an endoscope 652 can be inserted into a distal end of the shaft 658 andcommunication lines and/or power can be provided through the lumenextending through the shaft 658. The access retrieval device 650 caninclude an endoscope hood 654 that includes an endoscope hood mount 656attached to the distal end of the shaft 658, as depicted.

The endoscope hood 654 can extend distally of the endoscope 652, asdepicted and can be formed as a hemispherical pointed dome (e.g.,hemispherical distally elongated dome), such that a distal tip 660 ofthe endoscope hood 654 is pointed, as depicted. In some embodiments, thedistal tip 660 of the endoscope hood 654 can be more or less roundedthan depicted. In some embodiments, upon insertion of the distal end ofthe device 650 into the interstitial space between the pericardium andmyocardium, the endoscope hood 654 can lift the pericardial sac slightlyand create room for the endoscope 652 to capture a field of view thatextends distally from the shaft 658. In addition, the endoscope hood 654can keep material (e.g., fluid, tissue) from contacting a lens of theendoscope 652, thus providing a clear distally facing view.

In some embodiments, a magnet can be connected to a distal end of theendoscope hood 654, which can be of an opposite polarity in relation tothe hollow cylindrical magnet 636 depicted in FIG. 15B. In someembodiments, the magnet can be attached to an interior (e.g., same sideas endoscope 652) or an exterior of the endoscope hood 654. In someembodiments, the access retrieval device 650 can be used to retrieve theaccess tape 620. For example, the opposite polarity magnet on the accessretrieval device 650 can attract the hollow cylindrical magnet 636inserted in the access tape 620 and the magnets can magnetically connectwith one another. In some embodiments, the endoscope 652, shielded bythe endoscope hood 654 can be used to look for the light produced by theaccess propagation device 610 to navigate the endoscope hood 654 towardthe light to retrieve the magnet and access tape 620 connected with thehollow cylindrical magnet 636.

FIG. 17A is an isometric bottom view of another embodiment of an accessretrieval device 670 that includes an endoscope hood 674, in accordancewith embodiments of the present disclosure. As depicted, an endoscopehood 674 similar to that discussed in relation to FIG. 16 can beincluded on the distal end of a shaft 672. The shaft 672 can house anendoscope 676 at a distal end that can include a rotating view that canbe adjusted to look distally through the endoscope hood 674 or below theendoscope hood 674. The endoscope hood 674 can include a mount 678,connecting the endoscope hood 674 to the shaft 672, as discussed herein.

FIG. 17B is an isometric bottom view of another embodiment of a distalend of the access retrieval device depicted in FIG. 17A, in accordancewith embodiments of the present disclosure. In an example, an endoscopehood 674 can be included on a distal end of the shaft 672.

FIGS. 18A to 18C are isometric bottom views of additional embodiments ofan access retrieval device, in accordance with embodiments of thepresent disclosure. FIG. 18A depicts an embodiment of an accessretrieval device 690 that includes a shaft 692 with a yoke 694 thatincludes distally extending yoke arms 696-1, 696-2 attached to a distalend of the shaft 692. A distal end of the yoke 694 can be configured tohold a magnet 698 between two forks (e.g., yoke arms 696-1, 696-2) ofthe yoke 694 that extend distally. In an example, distal interior wallsof the yoke 694 can be parallel to one another.

In some embodiments, the yoke 694 can include holes formed in a distalend of each of the forks that can be configured to accept a swivel pin700, such that the swivel pin 700 can be inserted through the holes andthrough a magnet housing. In an example, the holes can be longitudinallyaligned and perpendicular to a longitudinal axis defined by the accessretrieval device 690 and the shaft 692. In some embodiments, instead offorming holes that extend all the way through each yoke arm 696-1,696-2, depressions can be made on an interior side of each yoke 694,which can each accept a swivel pin 700 formed on each side of the magnethousing 702. The swivel pins can be diametrically opposed to one anotherand can extend radially from the magnet housing 702. In someembodiments, the depressions can be made in the magnet housing 702 whichcan accept a swivel pin 700 formed on the inside of each of the yokearms 696-1 and 696-2. In some embodiments, the pins cab be integrallyformed in either the housing or yoke. Alternatively, an axle can passthrough the magnet housing 702, such that tips of the axle arediametrically opposed to one another and extend radially from the magnethousing 702.

In some embodiments, the magnet housing 702 and the yoke 694 can beformed of a polymer, such as a plastic, metal, and/or composite. In someembodiments, the magnet housing 702 can include an open through hole, asdepicted in FIG. 18A, which exposes a surface of the magnet 698. In anexample, the access retrieval device 690 depicted in FIG. 18A can beused to retrieve the access tape 620 depicted in FIG. 15B, in someembodiments. For instance, the magnet 698 in the distal pocket 622 ofthe access tape 620 can be magnetically attached to the magnetassociated with the access retrieval device 690.

In an example, the magnet 698 is suspended in a yoke 694 at the distalend of the shaft 692 and can be configured to swivel. This allowsatraumatic introduction, as the magnet housing 702 has a rounded backend. In some embodiments, the magnet housing 702 can have an elongateshape, which allows for torque transmission to a device being retrievedthat has a matching magnet socket to contain the elongate housing. Theswivel yoke 694 can allow the magnet 698 and magnet housing 702 toswivel with respect to the yoke 694 as a device being retrieved is beingpulled into place. In an example, because the magnet housing 702 andmagnet 698 can swivel, an alignment of the device being retrieved canchange with respect to the access retrieval device 690, allowing theretrieved device to be pulled into place within a profile of the accessretrieval device itself.

The retrieved device can be pulled by the attached magnet but theretrieval device 690 can apply this retrieving force with a pull or apush on its handle depending on whether the distal end of the retrieveddevice is pointing toward the operator or swiveled around to pointingaway from the operator. The transition between the two can be performedaround, for instance, the curve of the heart, in one smooth motion: Theoperator can magnetically attach to the retrieved device that ispointing toward him, in line with the shaft, pull it toward him, thenbegin a sideways sweep and then push it into a pocket or sinus such asthe transverse sinus such that the retrieved device is now pointing awayfrom him and back to parallel with the shaft.

A polarity of the magnet on the device being retrieved can causeautomatic alignment of the rotatable distal magnet 698 with respect tothe magnet on the device being retrieved as they come into closeproximity. The access retrieval device 690 depicted in FIG. 18A canallow for torque transmission to the device being retrieved (if thisdevice has a matching elongate feature that engages with aforementionedelongate retriever housing) when an axis of each device is alignedwithin about 45° to each other, either pointing forward or trailing. Forexample, when a longitudinal axis of the shaft is aligned within about45° of the device being retrieved, the shaft 692 can be turned andtorque can be transferred to the device being retrieved.

FIG. 18B depicts an embodiment of an access retrieval device 710 thatincludes a shaft 712 connected to a proximal end of the access retrievaldevice 710. In some embodiments, the shaft 712 can be connected to aproximal mount 714 of the access retrieval device 710. The accessretrieval device 710 can include a distal tip that includes a magnetsocket 718, further depicted in FIG. 18D. The access retrieval device710 can include a bendable and torqueable section 720 between theproximal mount 714 and the magnet socket 718, which can include a numberof universal joints, further depicted in FIG. 18D. The universal jointsallow for an angulation between a longitudinal axis of the shaft 712 andthe device being retrieved. The universal joints can provide gooddeflection of the magnetic socket 718, while still allowing for torquetransmission deflection angles of 90° or more with respect to alongitudinal axis of the shaft 712. A flexible sleeve 716 can be placedover the bendable and torqueable section to prevent material and/orfluid from contacting or being pinched by internal components of thebendable and torqueable section 720.

FIG. 18C depicts an embodiment of an access retrieval device 730 thatincludes a shaft 732, a distal end of which is connected to a retrievalball 734. The retrieval ball 734 can be formed from a material that hasa magnetic susceptibility, such that a magnet included on a device beingretrieved can be attracted to the retrieval ball 734. In someembodiments, the retrieval ball 734 can be a magnet.

In some embodiments, a separation rod 736 can extend from a proximal endof the shaft 732, through a central lumen of the shaft 732, through theretrieval ball 734, and can exit through a rod port in a distal end ofthe retrieval ball 734, as depicted. In some embodiments, the rod portcan be aligned with a longitudinal axis of the shaft 712 and accessretrieval device 730. The separation rod 736 can be deployed by acontrol connected to the proximal end of the shaft 732, as depicted inFIG. 18F, to separate the access retrieval device 730 and the devicebeing retrieved. For example, the separation rod 736 can separate theretrieval device 730 and the device being retrieved to help reduce amagnetic force between the access retrieval device 730 and the devicebeing removed. Upon reduction of the magnetic force, the accessretrieval device 730 can be pulled away from the device being retrieved,while leaving the device being retrieved substantially in place. In astored state, a distal tip of the separation rod 736 can sit flush,recessed, or slightly raised with respect to a surface of the retrievalball 734. Upon activation of the control, the separation rod 736 can bemoved axially and distally, such that a distal tip of the separation rod736 is raised from its position in the stored state to a deployed state,thus allowing separation of the access retrieval device 730 from thedevice being retrieved.

FIG. 18D depicts an isometric side view of a distal end of the accessretrieval device 710 in FIG. 18B, in accordance with embodiments of thepresent disclosure. The access retrieval device 710 can include theshaft 712, the flexible sleeve 716, which has been rolled back in FIG.18D to expose the internal components of the access retrieval device710. The shaft 712 can be connected to the proximal mount 714, which isconnected to the proximal universal joint 750. In some embodiments, theproximal universal joint 750 can be directly connected to a distaluniversal joint 752 with a cross journal 764. However, as depicted, theaccess retrieval device 710 can include N universal joints 754 betweenthe proximal universal joint 750 and the distal universal joint 752,where N can be a number greater than 1. Each of the universal joints 754can include cross journal holes 756 in which individual journals of eachcross journal 764 can be inserted to connect the universal joints 754.The distal universal joint 752 can include an elongate socket 758, whichcan house a magnet 760 or another magnetically susceptible material. Themagnet 760 can have a flat face and can include a rod port that passesthrough a center of the magnet (e.g., is axially aligned with alongitudinal axis of the magnet 760).

As discussed in relation to FIG. 18C, the separation rod 762 can bedeployed by a control connected to the proximal end of the shaft 712, asdepicted in FIG. 18E, to separate the access retrieval device 710 andthe device being retrieved. For example, the separation rod 762 canseparate the retrieval device 710 and the device being retrieved to helpreduce a magnetic force between the access retrieval device 710 and thedevice being removed. In a stored state, a distal tip of the separationrod 762 can sit flush, recessed, or slightly raised with respect to asurface of the magnet 760. Upon activation of the control, theseparation rod 762 can be moved axially and distally, such that a distaltip of the separation rod 762 is raised from its position in the storedstate to a deployed state, thus allowing separation of the accessretrieval device 710 from the device being retrieved.

In some embodiments, the device being retrieved can have a magnet thatdoes not have a hole in its center and can have a flat uninterruptedsurface that can be pushed on by the separation rod 762. Alternatively,or in addition, the separation rod 762 can include a push plate or pushobject connected to its distal end. For example, the push plate can beconnected to the distal end of the separation rod 762 so a planarsurface of the push plate is parallel with the flat surface of themagnet 760. Thus if the device being retrieved has a magnet with a holein its center, the push plate can still push on the magnet to separatethe devices. Alternatively, the separation rod 762 can have a pushobject which has a larger diameter than a hole included in the magnetassociated with the device being retrieved.

As depicted, the separation rod 762 can travel through a center of theuniversal joints. The cross journals 764 can each have a hole formed ina middle of each cross journal 764 to allow the separation rod 762 topass from the distal end of the access retrieval device 710 to theproximal end of the access retrieval device 710. The separation rod 762can be of sufficient stiffness that it does not fold over as it extendsfrom the magnet in a deployed state, but it does flex going through thecross journals 764, which guide it from bowing outward undercompression.

The access retrieval device 710 can include an elongate socket 758 whichcan accept a mating surface of the device being retrieved (e.g., magnetassociated with the device being retrieved). For example, the devicebeing retrieved can slip (e.g., can be configured to fit) inside a lumenformed by the elongate socket 758. Alternatively, the device beingretrieved can slip over the elongate socket 758. The elongated socket758 can aid in transferring torque to the device being retrieved, insome embodiments.

FIGS. 18E to 18G depict isometric bottom views of the additionalembodiments of the access retrieval devices depicted in FIGS. 18A to18C, in accordance with embodiments of the present disclosure. FIG. 18Edepicts the handle 770 located at the proximal end of the shaft 772 ofthe access retrieval device 690 in FIG. 18A. FIG. 18F depicts the handle780 located at the proximal end of the shaft 712 of the access retrievaldevice 710 in FIG. 18B. The handle 780 can include a push button control782 to deploy the separation rod 762. The push button control 782 can beand distally axially depressed, in an embodiment, resulting in thedistal extension of the separation rod 762. FIG. 18G depicts the handle790 located at the proximal end of the shaft 732 of the access retrievaldevice 730 in FIG. 18C. The handle 790 can include a push button control792 to deploy the separation rod 736. The push button control can bedistally and axially depressed, in an embodiment, resulting in thedistal extension of the separation rod 736.

FIG. 19A depicts a side view of an endoscope hood device 810, inaccordance with embodiments of the present disclosure. The endoscopehood device 810 can include an endoscope hood 812 that has a port 814for an endoscope 816 to pass through the endoscope hood 812 at aproximal end of the endoscope hood 812. The endoscope hood 812 can forman arc, beginning at an endoscope proximal base 818 and extending upwardand distally from the endoscope 816. The distal portion of the endoscopehood can be curved downward to a distal tip 820 to form the arc, whichcan reduce a potential for injury upon introduction into anatomicspaces, tissue planes, and interstitial space such as theintrapericardial space. An endoscope proximal base 818 of the endoscopehood 812 can include a hinge pin slot, through which a hinge pin 822 canpass through. The hinge pin 822 can pass through an endoscope base 830,as depicted in FIG. 19C, which can be connected around a distal end ofthe endoscope 816 and/or distal end of an inner tube 824. The endoscopeproximal base 818 can have a vertical relief slot 850, allowing it to beslipped over the endoscope 816 and/or inner tube 824 and fastened so itdoes not move axially.

The endoscope 816 can be positioned at a distal end of an inner tube824, in some embodiments. In some embodiments, the inner tube 824 can bea shaft associated with the endoscope. A push/pull tube 832 can becoaxial with the inner tube 824 and can be slid axially along the innertube 824 (e.g., protracted, retracted) to move the endoscope hood 812. Adistal end of the push/pull tube 832 can include a push/pull plate 834,which extends vertically from the push pull tube 832 and can beconnected to the endoscope hood 812 via a hinge wire 836, as depicted.

In an example, as the push/pull tube 832 is moved axially and distally(e.g., protracted), the endoscope hood 812 can be deflected downward. Asthe push/pull tube is moved axially and proximally (e.g., retracted),the endoscope hood 812 can be deflected upward. For example, byprotracting the push/pull tube 832 with respect to the inner tube 824,the push/pull plate 834 can be moved distally, thus causing the hingepin 836 to translate the distal motion to the endoscope hood 812, towhich it can be rotatably connected (e.g., can pass through a hinge pinhole in the push/pull plate 834 and a hinge pin hole in the endoscopehood 812). In some embodiments, a relief slot 852 can be formed around ahinge pin hole disposed in the endoscope hood 812, such that theendoscope hood 812 can be deflected upward and downward without thehinge pin 836 contacting the endoscope hood 812. Upon translation of thedistal motion to the endoscope hood 812, the endoscope hood 812 canrotate about the hinge pin 822, causing the endoscope hood (e.g., distaltip 820) to move (e.g., deflect) upwardly or downwardly.

In some embodiments, the endoscope hood 812 can include a fluid port 838that is in fluid communication with a fluid lumen 842 defined by a fluidtube 840 via a fluid lumen 844 extending through the endoscope hood 812.In some embodiments, the fluid tube 840 can be inserted into a recessedtube mounting bore 846 that has a diameter that closely matches that ofthe fluid tube 840. In some embodiments, a diameter of the fluid lumen844 can be less than the recessed tube mounting bore 846. In an example,irrigation liquid can be expelled from the fluid port 838, a gas can beexpelled from the fluid port 838 for insufflation, and/or a vacuum canbe drawn through the fluid port 838. The endoscope hood device 810 canhave the ability to tent the pericardium while providing the ability toflush a field of view of the endoscope 816 with fluid, clear the fieldvia vacuum, and/or gently grasp structures such as the pericardium forincision or left atrial appendage to assist with a deployment of a clipat its base, in some examples. The ability to gently tease the leftatrial appendage into a clip, such as an AtriClip®, produced byAtriCure, without an extra tool, such as a kitner or graspers cansimplify a procedure and minimize a number of instruments to be handled.

FIG. 19B depicts an isometric side view of the endoscope hood device 810in FIG. 19A, in accordance with embodiments of the present disclosure.An opposite side of the endoscope hood device 810 is depicted in FIG.19B in relation to the view depicted in FIG. 19A. FIG. 19C depicts across-sectional side view of the endoscope hood device 810 in FIG. 19A,in accordance with embodiments of the present disclosure. As shown, theendoscope hood 812 can include an inner lumen 844 that connects thefluid port 838 with the fluid tube 840. FIG. 19D depicts an isometricfront and side view of the endoscope hood device 810 in FIG. 19A, inaccordance with embodiments of the present disclosure. As depicted, theendoscope base 830 can include the vertical relief slot 850, aspreviously discussed herein. FIG. 19E depicts an isometric bottom,front, and side view of the endoscope hood device 810 in FIG. 19A, inaccordance with embodiments of the present disclosure.

FIG. 19F depicts an isometric bottom and side component view of theendoscope hood device 810 in FIG. 19A, in accordance with embodiments ofthe present disclosure. As discussed herein, the endoscope hood device810 can include the endoscope hood 812, the endoscope base 830, thefluid tube 840, the hinge pin 822, the push/pull tube 832, and the innertube 824, which can house the endoscope 816 at its distal end.

Embodiments are described herein of various apparatuses, systems, and/ormethods. Numerous specific details are set forth to provide a thoroughunderstanding of the overall structure, function, manufacture, and useof the embodiments as described in the specification and illustrated inthe accompanying drawings. It will be understood by those skilled in theart, however, that the embodiments may be practiced without suchspecific details. In other instances, well-known operations, components,and elements have not been described in detail so as not to obscure theembodiments described in the specification. Those of ordinary skill inthe art will understand that the embodiments described and illustratedherein are non-limiting examples, and thus it can be appreciated thatthe specific structural and functional details disclosed herein may berepresentative and do not necessarily limit the endoscope of theembodiments, the endoscope of which is defined solely by the appendedclaims.

Reference throughout the specification to “various embodiments,” “someembodiments,” “one embodiment,” or “an embodiment”, or the like, meansthat a particular feature, structure, or characteristic described inconnection with the embodiment(s) is included in at least oneembodiment. Thus, appearances of the phrases “in various embodiments,”“in some embodiments,” “in one embodiment,” or “in an embodiment,” orthe like, in places throughout the specification, are not necessarilyall referring to the same embodiment. Furthermore, the particularfeatures, structures, or characteristics may be combined in any suitablemanner in one or more embodiments. Thus, the particular features,structures, or characteristics illustrated or described in connectionwith one embodiment may be combined, in whole or in part, with thefeatures, structures, or characteristics of one or more otherembodiments without limitation given that such combination is notillogical or non-functional.

It will be appreciated that the terms “proximal” and “distal” may beused throughout the specification with reference to a clinicianmanipulating one end of an instrument used to treat a patient. The term“proximal” refers to the portion of the instrument closest to theclinician and the term “distal” refers to the portion located furthestfrom the clinician. It will be further appreciated that for concisenessand clarity, spatial terms such as “vertical,” “horizontal,” “up,” and“down” may be used herein with respect to the illustrated embodiments.However, surgical instruments may be used in many orientations andpositions, and these terms are not intended to be limiting and absolute.

Although at least one embodiment for determination of a medical devicehas been described above with a certain degree of particularity, thoseskilled in the art could make numerous alterations to the disclosedembodiments without departing from the spirit or endoscope of thisdisclosure. All directional references (e.g., upper, lower, upward,downward, left, right, leftward, rightward, top, bottom, above, below,vertical, horizontal, clockwise, and counterclockwise) are only used foridentification purposes to aid the reader's understanding of the presentdisclosure, and do not create limitations, particularly as to theposition, orientation, or use of the devices. Joinder references (e.g.,affixed, attached, coupled, connected, and the like) are to be construedbroadly and can include intermediate members between a connection ofelements and relative movement between elements. As such, joinderreferences do not necessarily infer that two elements are directlyconnected and in fixed relationship to each other. It is intended thatall matter contained in the above description or shown in theaccompanying drawings shall be interpreted as illustrative only and notlimiting. Changes in detail or structure can be made without departingfrom the spirit of the disclosure as defined in the appended claims.

Any patent, publication, or other disclosure material, in whole or inpart, that is said to be incorporated by reference herein isincorporated herein only to the extent that the incorporated materialsdoes not conflict with existing definitions, statements, or otherdisclosure material set forth in this disclosure. As such, and to theextent necessary, the disclosure as explicitly set forth hereinsupersedes any conflicting material incorporated herein by reference.Any material, or portion thereof, that is said to be incorporated byreference herein, but which conflicts with existing definitions,statements, or other disclosure material set forth herein will only beincorporated to the extent that no conflict arises between thatincorporated material and the existing disclosure material.

What is claimed is:
 1. A medical device, comprising: an elongate outersheath that extends along a sheath longitudinal axis and defines acentral lumen extending therethrough, the elongate outer sheathcomprising a proximal sheath portion and a distal sheath portion; afirst guidewire comprising a first guidewire end and a second guidewireend, the first guidewire extending from the first and second guidewireends through the central lumen and forming a distal looped portion; andan occlusion device disposed at a distal end of an elongate flexibleshaft, the elongate flexible shaft extending from the proximal sheathportion through the central lumen, wherein: the occlusion deviceincludes a guide lumen through which the first guide wire passes; thefirst guidewire is configured to be moved distally with respect to theouter sheath, such that the distal looped portion is disposed distallywith respect to the distal sheath portion; and the occlusion device isconfigured to be moved along the first guidewire.
 2. The medical deviceof claim 1, wherein the distal looped portion and the occlusion deviceare stored within the central lumen in an undeployed state.
 3. Themedical device of claim 1, wherein the distal looped portion and theocclusion device are located distally with respect to the distal sheathportion in a deployed state.
 4. The medical device of claim 1, wherein:the occlusion device is configured to be moved distally along the firstguidewire and about the distal looped portion; and the occlusion deviceis turned from a straight orientation, the straight orientation beingaligned with the sheath longitudinal axis, as the occlusion device ismoved distally along the first guidewire and about the distal loopedportion.
 5. The medical device of claim 1, wherein an endoscope extendsthrough the central lumen from the proximal sheath portion to the distalsheath portion.
 6. The medical device of claim 1, further comprising asteerable expanding shroud disposed distally of the distal sheathportion, wherein the steerable expanding shroud forms a lumen in whichthe distal looped portion and the occlusion device extend.
 7. Themedical device of claim 6, wherein the steerable expanding shroud isconfigured to be stored in the central lumen in an undeployed state. 8.The medical device of claim 6, wherein a longitudinal length of thesteerable expanding shroud and an axial deflection of the steerableexpanding shroud are adjustable via a control located proximally fromthe distal sheath portion.
 9. The medical device of claim 6, wherein thesteerable expanding shroud is connected to a distal end of an innersheath, wherein the inner sheath is disposed within the central lumenand is coaxial with the outer sheath.
 10. The medical device of claim 9,wherein the inner sheath is configured to axially move with respect tothe outer sheath.
 11. A medical device, comprising: an elongate outersheath that extends along a sheath longitudinal axis and defines acentral lumen extending therethrough, the elongate outer sheathcomprising a proximal sheath portion and a distal sheath portion; afirst guidewire comprising a first guidewire end and a second guidewireend and a second guidewire comprising a third guidewire end and a fourthguidewire end, the first and second guidewires extending from theirrespective guidewire ends through the central lumen and forming a firstguidewire distal looped portion and a second guidewire distal loopedportion, respectively; and an occlusion device disposed at a distal endof an elongate flexible shaft, the elongate flexible shaft extendingfrom the proximal sheath portion through the central lumen, wherein: theocclusion device includes a first guide lumen through which the firstguidewire passes and a second guide lumen through which the secondguidewire passes; the occlusion device includes a first jaw to which thefirst guide lumen is connected and a second jaw to which the secondguide lumen is connected; and the first jaw and the second jaw areconnected via a pivot point.
 12. The medical device of claim 11, whereinthe first guide lumen is aligned with a longitudinal axis of the firstjaw and the second guide lumen is aligned with a longitudinal axis ofthe second jaw.
 13. The medical device of claim 12, wherein the pivotpoint is located at a proximal portion of the first jaw and the secondjaw.
 14. The medical device of claim 13, wherein the first jaw and thesecond jaw are configured to be closed upon one another.
 15. The medicaldevice of claim 14, wherein: the first jaw is configured to be moveddistally along the first guidewire and about the first guidewire distallooped portion; and the second jaw is configured to be moved distallyalong the second guidewire and about the second distal looped portion inunison with the first jaw.
 16. The medical device of claim 15, whereinthe first jaw and the second jaw are turned from a straight orientation,the straight orientation being aligned with the sheath longitudinalaxis, as the first jaw and the second jaw are moved distally along thefirst and second guidewire and about the first and second distal loopedportions.
 17. A method of using a medical device, comprising: deployinga first guidewire distal looped portion and a second guidewire distallooped portion of the medical device from a distal end of an elongateouter sheath that extends along a sheath longitudinal axis and defines acentral lumen extending therethrough; guiding an occlusion devicedisposed at a distal end of an elongate flexible shaft along the firstguidewire distal looped portion and the second guidewire distal loopedportion; and activating the occlusion device via a control disposedproximally of the distal end of the elongate outer sheath.
 18. Themethod of claim 17, wherein the method includes guiding the occlusiondevice from a straight orientation, the straight orientation beingaligned with the sheath longitudinal axis, by causing the occlusiondevice to be moved distally about the first and second distal loopedportions.
 19. The method of claim 18, wherein activating the occlusiondevice includes causing a first jaw and a second jaw of the occlusiondevice to be opened, wherein a first guide lumen through which the firstguidewire distal looped portion passes is connected to the first jaw anda second guide lumen through which the second guidewire distal loopedportion passes is connected to the second jaw.
 20. The method of claim17, wherein deploying the first guidewire distal looped portion and thesecond guidewire distal looped portion from the distal end of theelongate outer sheath includes laterally expanding the first guidewiredistal looped portion and the second guidewire distal looped portionwith respect to the sheath longitudinal axis.